Bringing innovative wound care polymer materials to the market: Challenges, developments, and new trends.

The development of innovative products for treating acute and chronic wounds has become a significant topic in healthcare, resulting in numerous products and innovations over time. The growing number of patients with comorbidities and chronic diseases, which may significantly alter, delay, or inhibit normal wound healing, has introduced considerable new challenges into the wound management scenario. Researchers in academia have quickly identified promising solutions, and many advanced wound healing materials have recently been designed; however, their successful translation to the market remains highly complex and unlikely without the contribution of industry experts. This review article condenses the main aspects of wound healing applications that will serve as a practical guide for researchers working in academia and industry devoted to designing, evaluating, validating, and translating polymer wound care materials to the market. The article highlights the current challenges in wound management, describes the state-of-the-art products already on the market and trending polymer materials, describes the regulation pathways for approval, discusses current wound healing models, and offers a perspective on new technologies that could soon reach consumers. We envision that this comprehensive review will significantly contribute to highlighting the importance of networking and exchanges between academia and healthcare companies. Only through the joint of these two actors, where innovation, manufacturing, regulatory insights, and financial resources act in harmony, can wound care products be developed efficiently to reach patients quickly and affordably.

Causes of Moderate and Severe Anaemia in a High-HIV and TB-Prevalent Adult Population in the Eastern Cape Province, South Africa.

BACKGROUND: Anaemia affects one in four adults in South Africa, with a higher prevalence in persons with HIV and tuberculosis. The aim of this study is to characterise the causes of anaemia in primary care and a district hospital setting. METHODS: A cross-sectional study design investigated a purposive sample of adult males and non-pregnant females at two community health centres and a hospital casualty and outpatients. Fingerpick blood haemoglobin was measured with HemoCueHb201+. Those with moderate and severe anaemia underwent clinical examination and laboratory tests. RESULTS: Of 1327 patients screened, median age was 48 years, and 63.5% were female. Of 471 (35.5%) with moderate and severe anaemia on HemoCue, 55.2% had HIV, 16.6% tuberculosis, 5.9% chronic kidney disease, 2.6% cancer, and 1.3% heart failure. Laboratory testing confirmed 227 (48.2%) with moderate and 111 (23.6%) with severe anaemia, of whom 72.3% had anaemia of inflammation, 26.5% iron-deficiency anaemia, 6.1% folate deficiency, and 2.5% vitamin B12 deficiency. Overall, 57.5% had two or more causes of anaemia. Multivariate modelling showed that patients with severe anaemia were three times more likely to have tuberculosis (OR = 3.1, 95% CI = 1.5-6.5; p-value = 0.002). Microcytosis was present in 40.5% with iron deficiency, macrocytosis in 22.2% with folate deficiency, and 33.3% with vitamin B12 deficiency. The sensitivities of the reticulocyte haemoglobin content and % hypochromic red blood cells in diagnosing iron deficiency were 34.7% and 29.7%, respectively. CONCLUSIONS: HIV, iron deficiency, and tuberculosis were the most prevalent causes of moderate and severe anaemia. The majority had multiple causes. Iron, folate, and vitamin B12 deficiencies should be identified by biochemical testing rather than by red cell volume.

Nanocarriers for Skin Applications: Where Do We Stand?

Skin penetration of active molecules for treatment of diverse diseases is a major field of research owing to the advantages associated with the skin like easy accessibility, reduced systemic-derived side effects, and increased therapeutic efficacy. Despite these advantages, dermal drug delivery is generally challenging due to the low skin permeability of therapeutics. Although various methods have been developed to improve skin penetration and permeation of therapeutics, they are usually aggressive and could lead to irreversible damage to the stratum corneum. Nanosized carrier systems represent an alternative approach for current technologies, with minimal damage to the natural barrier function of skin. In this Review, the use of nanoparticles to deliver drug molecules, genetic material, and vaccines into the skin is discussed. In addition, nanotoxicology studies and the recent clinical development of nanoparticles are highlighted to shed light on their potential to undergo market translation.

Surface wave elastography is a reliable method to correlate muscle elasticity, torque, and electromyography activity level.

The shear elastic modulus is one of the most important parameters to characterize the mechanical behavior of soft tissues. In biomechanics, ultrasound elastography is the gold standard for measuring and mapping it locally in skeletal muscle in vivo. However, their applications are limited to the laboratory or clinic. Thus, low-frequency elastography methods have recently emerged as a novel alternative to ultrasound elastography. Avoiding the use of high frequencies, these methods allow obtaining a mean value of bulk shear elasticity. However, they are frequently susceptible to diffraction, guided waves, and near field effects, which introduces biases in the estimates. The goal of this work is to test the performance of the non-ultrasound surface wave elastography (NU-SWE), which is portable and is based on new algorithms designed to correct the incidence of such effects. Thus, we show its first application to muscle biomechanics. We performed two experiments to assess the relationships of muscle shear elasticity versus joint torque (experiment 1) and the electromyographic activity level (experiment 2). Our results were comparable regarding previous works using the reference ultrasonic methods. Thus, the NU-SWE showed its potentiality to get wide the biomechanical applications of elastography in many areas of health and sports sciences.

A Dual Fluorescence-Spin Label Probe for Visualization and Quantification of Target Molecules in Tissue by Multiplexed FLIM-EPR Spectroscopy.

Simultaneous visualization and concentration quantification of molecules in biological tissue is an important though challenging goal. The advantages of fluorescence lifetime imaging microscopy (FLIM) for visualization, and electron paramagnetic resonance (EPR) spectroscopy for quantification are complementary. Their combination in a multiplexed approach promises a successful but ambitious strategy because of spin label-mediated fluorescence quenching. Here, we solved this problem and present the molecular design of a dual label (DL) compound comprising a highly fluorescent dye together with an EPR spin probe, which also renders the fluorescence lifetime to be concentration sensitive. The DL can easily be coupled to the biomolecule of choice, enabling in vivo and in vitro applications. This novel approach paves the way for elegant studies ranging from fundamental biological investigations to preclinical drug research, as shown in proof-of-principle penetration experiments in human skin ex vivo.

Environmental Liquid Cell Technique for Improved Electron Microscopic Imaging of Soft Matter in Solution.

Liquid-phase transmission electron microscopy is a technique for simultaneous imaging of the structure and dynamics of specimens in a liquid environment. The conventional sample geometry consists of a liquid layer tightly sandwiched between two Si3N4 windows with a nominal spacing on the order of 0.5 µm. We describe a variation of the conventional approach, wherein the Si3N4 windows are separated by a 10-µm-thick spacer, thus providing room for gas flow inside the liquid specimen enclosure. Adjusting the pressure and flow speed of humid air inside this environmental liquid cell (ELC) creates a stable liquid layer of controllable thickness on the bottom window, thus facilitating high-resolution observations of low mass-thickness contrast objects at low electron doses. We demonstrate controllable liquid thicknesses in the range 160 ± 34 to 340 ± 71 nm resulting in corresponding edge resolutions of 0.8 ± 0.06 to 1.7 ± 0.8 nm as measured for immersed gold nanoparticles. Liquid layer thickness 40 ± 8 nm allowed imaging of low-contrast polystyrene particles. Hydration effects in the ELC have been studied using poly-N-isopropylacrylamide nanogels with a silica core. Therefore, ELC can be a suitable tool for in situ investigations of liquid specimens.

Polyglycerol-Based Thermoresponsive Nanocapsules Induce Skin Hydration and Serve as a Skin Penetration Enhancer.

The use of penetration enhancers (chemical or physical) has been proven to dramatically improve the penetration of therapeutics. Nevertheless, their use poses great risks, as they can lead to permanent damage of the skin, reduce its barrier efficiency, and result in the intrusion of harmful substances. Among the most used skin penetration enhancers, water is greatly accepted because skin quickly recovers from its exposure. Nanocapsules (NCs) represent a promising combination of the carrier system and penetration enhancer because their water-containing void combined with their polymer-based shell can be used to induce high local skin hydration, while simultaneously aiding the transport of drugs across the skin barrier. In this study, NCs were synthesized with a void core of 100 nm in diameter, a thermoresponsive shell based on different ratios of poly(N-isopropylacrylamide) and poly(N-isopropylmethacrylamide) as thermoresponsive polymers, and dendritic polyglycerol as a macromolecular cross-linker. These NCs can shrink or swell upon a thermal trigger, which was used to induce the release of the entrapped water in a controlled fashion. The interactions and effects of thermoresponsive NCs on the stratum corneum of excised human skin were investigated using fluorescence microscopy, high-resolution optical microscopy, and stimulated Raman spectromicroscopy. It could be observed that the thermoresponsive NCs increase the amount of deuterated water that penetrated into the viable epidermis. Moreover, NCs increased the skin penetration of a high-molecular weight dye (Atto Oxa12 NHS ester, MW = 835 g/mol) with respect to formulations in water or 30% DMSO, emphasizing the features of the NCs as a skin penetration enhancer.

GALIUS: an ultrafast imaging spectrograph for the study of lightning.

We present the main parameters, design features, and optical characterization of the GrAnada LIghtning Ultrafast Spectrograph (GALIUS): a portable, ground-based spectrographic system intended for analysis of the spectroscopic signature of lightning. It has been designed to measure the spectra of the light emitted from natural and triggered lightning and artificial electrostatic discharges at recording speeds up to 2.1 Mfps. It includes a set of four interchangeable grisms covering different spectral ranges (from 375 nm to 854.5 nm) with spectral resolutions from 0.29 nm to 0.76 nm. A set of 10 collector lenses allows the recording of the spectrum of electrostatic discharges and lightning in different scenarios.

Síndrome de Zinner en un paciente politraumatizado / Zinner's syndrome in a polytrauma patient

Objetivo: Reportar dos nuevos casos de Síndrome de Zinner, una variante anatómica poco prevalente y conocida, con riesgo de originar alteraciones. Método: Descripción de dos casos de Síndrome de Zinner presentados en nuestro centro, durante estudio por epididimitis aguda de repetición y tras traumatismo renal grado IV. Revisión de la literatura hasta la fecha, centrada en su diagnóstico y posibles complicaciones. Resultado: El manejo conservador del paciente politraumatizado permitió preservar el riñón, manteniendo una función renal normal. Es el primer caso de síndrome de Zinner diagnosticado en este contexto clínico. Conclusiones: El Síndrome de Zinner es una entidad poco frecuente y que pasa inadvertida en muchas ocasiones dada la escasa sintomatología que produce

Objective: To report two Zinner's syndrome cases, a rare anatomical variant with risk of complications. Methods: Analysis of two Zinner syndrome cases, detected during acute recurrent epididimytis and after a grade IV renal trauma. Review of the literature focusing on its diagnosis and possible complications. Results: The conservative management of the polytrauma patient allowed to preserve the kidney, while maintaining normal renal function. It is the first Zinner`s syndrome diagnosed in this clinical context. Conclusions: Zinner`s syndrome is a rare entity and often goes unnoticed because of the few symptoms it produces

[Zinner`s syndrome in a polytrauma patient.] / Síndrome de Zinner en un paciente politraumatizado.

OBJECTIVE: To report two Zinner`s syndrome cases, a rare anatomical variant with risk of complications. METHODS: Analysis of two Zinner syndrome cases, detected during acute recurrent epididimytis and after a grade IV renal trauma. Review of the literature focusing on its diagnosis and possible complications. RESULTS: The conservative management of the polytrauma patient allowed to preserve the kidney, while maintaining normal renal function. It is the first Zinner`s syndrome diagnosed in this clinical context. CONCLUSIONS: Zinner`s syndrome is a rare entity and often goes unnoticed because of the few symptoms it produces.

OBJETIVO: Reportar dos nuevos casos de Síndrome de Zinner, una variante anatómica poco prevalente y conocida, con riesgo de originar alteraciones. MÉTODO: Descripción de dos casos de Síndrome de Zinner presentados en nuestro centro, durante estudio por epididimitis aguda de repetición y tras traumatismo renal grado IV. Revisión de la literatura hasta la fecha, centrada en su diagnóstico y posibles complicaciones. RESULTADO: El manejo conservador del paciente politraumatizado permitió preservar el riñón, manteniendo una función renal normal. Es el primer caso de síndrome de Zinner diagnosticado en este contexto clínico. CONCLUSIONES: El Síndrome de Zinner es una entidad poco frecuente y que pasa inadvertida en muchas ocasiones dada la escasa sintomatología que produce.

Crossing biological barriers with nanogels to improve drug delivery performance.

The current limitations in the use of nanocarriers to treat constantly evolving diseases call for the design of novel and smarter drug delivery systems (DDS). Nanogels (NGs) are three-dimensional crosslinked polymers with dimensions on the nanoscale and with a great potential for use in the biomedical field. Particular interest focuses on their application as DDS to minimize severe toxic effects and increase the therapeutic index of drugs. They have recently gained attention, since they can include responsive modalities within their structure, which enable them to excerpt a therapeutic function on demand. Their bigger sizes and controlled architecture and functionality, when compared to non-crosslinked polymers, make them particularly interesting to explore novel modalities to cross biological barriers. The present review summarizes the most significant developments of NGs as smart carriers, with focus on smart modalities to cross biological barriers such as cellular membrane, tumor stroma, mucose, skin, and blood brain barrier. We discuss the properties of each barrier and highlight the importance that the NG design has on their capability to overcome them and deliver the cargo at the site of action.

Understanding the elusive protein corona of thermoresponsive nanogels.

AIM: We analyzed the protein corona of thermoresponsive, poly(N-isopropylacrylamide)- or poly(N-isopropylmethacrylamide)-based nanogels. MATERIALS & METHODS: Traces of protein corona detected after incubation in human serum were characterized by proteomics and dynamic light scattering in undiluted serum. RESULTS: Apolipoprotein B-100 and albumin were the main components of the protein coronae. For dendritic polyglycerol-poly(N-isopropylacrylamide) nanogels at 37°C, an increase in adsorbed immunoglobulin light chains was detected, followed by partially reversible nanogel aggregation. All nanogels in their hydrophilic state are colloidally stable in serum and bear a dysopsonin-rich protein corona. CONCLUSION: We observed strong changes in NG stability upon slight alterations in the composition of the protein coronae according to nanogel solvation state. Nanogels in their hydrophilic state possess safe protein coronae.

Semi-interpenetrated, dendritic, dual-responsive nanogels with cytochrome c corona induce controlled apoptosis in HeLa cells.

The use of thermoresponsive nanogels (NGs) allows the controlled release of therapeutic molecules upon a thermal switch. Usually, this strategy involves the use of temperature increase to activate cargo expulsion from shrinking NGs. In this study, poly(N-isopropylacrylamide) (pNIPAM)-based NGs were involved in the release of a therapeutic protein corona by temperature decrease. NGs based on dendritic polyglycerol (dPG) and thermoresponsive pNIPAM were semi-interpenetrated with poly(4-acryloylamine-4-(carboxyethyl)heptanodioic acid) (pABC). The resulting semi-interpenetrated NGs retain the thermoresponsive properties of pNIPAM, together with pH-responsive, dendritic pABC as a secondary network, in one single nanoparticle. Semi-interpenetrated polymer network (SIPN) NGs are stable in physiological conditions, exhibit a reversible phase transition at 35 °C, together with tunable electrophoretic mobilities around the body temperature. The binding of cytochrome c (cyt c) was successful on SIPN NGs in their collapsed state at 37 °C. Upon cooling of the samples to room temperature, the swelling of the NG effectively boosted the release of cyt c, as compared with the same kept at constant 37 °C. These responsive SIPN NGs were able to deliver cyt c to cancer cells and specifically induce apoptosis at 30 °C, while the cells remained largely unaffected at 37 °C. In this way, we show therapeutic efficacy of thermoresponsive NGs as protein carriers and their efficacy triggered by temperature decrease. We envision the use of such thermal trigger as relevant for the treatment of superficial tumors, in which induction of apoptosis can be controlled by the application of local cooling agents.

[Mini-laparoscopic pyeloplasty.] / Pieloplastia por Minilap..

Continued progresses in the field of laparoscopy have been introduced in urological surgery. With the development of smaller instrumental minilaparoscopy was born seeking to reduce abdominal trauma and improve cosmetic scars, obtaining similar or better results than conventional laparoscopy. OBJECTIVE: The objective of this paper is to evaluate the results and reproducibility of mini-laparoscopic pyeloplasty. METHODS: A literature review and a bibliographic search in PubMed were performed. We describe the technique used in the "Hospital Marqués de Valdecilla" (HUMV), Santander (Spain). RESULTS: 60 articles about mini-laparoscopy were found. Although there are few reported minilap pyeloplasty series, they offer excellent cosmetic and functional results. We analyze operative time, complications, postoperative hospital stay, conversion rate, functional and cosmetic results, and we compare them with conventional laparoscopic pyeloplasty. CONCLUSIONS: More reported series are necessary but it has been proved that minilap pyeloplasty is a reproducible and safe technique with excellent results.

Pieloplastia robótica y laparoscópica / Robot-assisted and laparoscopic pyeloplasty

Los continuos avances en el campo de la laparoscopia han ido siendo introducidos progresivamente en la cirugía urológica. Con el desarrollo de instrumental de menor tamaño nace la minilaparoscopia, buscando reducir el trauma abdominal y mejorar la cosmética de las cicatrices, obteniendo unos resultados similares o mejores a los logrados en la laparoscopia convencional. Objetivo: El objetivo es evaluar los resultados y la reproducibilidad de la pieloplastia por minilap. Método: Para ello se ha realizado una revisión de la literatura y una búsqueda bibliográfica en PubMed. Describimos la técnica quirúrgica realizada en el Hospital Universitario Marqués de Valdecilla, Santander (HUMV). Resultados: se encontraron más de 60 artículos que hacían referencia a la minilaparoscopia. Aunque a día de hoy son escasas las series reportadas de pieloplastia por minilap, estas ofrecen unos resultados excelentes. Analizamos los datos de tiempo quirúrgico, complicaciones, estancia hospitalaria, tasa de conversión, resultado funcional y cosmético, comparándolos con la pieloplastia laparoscópica convencional. Conclusiones: Aunque es necesario que se reporten más series, se ha demostrado que la pieloplastia por minilap es una técnica reproducible y segura, que otorga así mismo unos resultados excelentes

Continued progresses in the field of laparoscopy have been introduced in urological surgery. With the development of smaller instrumental minilaparoscopy was born seeking to reduce abdominal trauma and improve cosmetic scars, obtaining similar or better results than conventional laparoscopy. Objective: The objective of this paper is to evaluate the results and reproducibility of mini-laparoscopic pyeloplasty. Methods: A literature review and a bibliographic search in PubMed were performed. We describe the technique used in the Hospital Marqués de Valdecilla (HUMV), Santander (Spain). Results: 60 articles about mini-laparoscopy were found. Although there are few reported minilap pyeloplasty series, they offer excellent cosmetic and functional results We analyze operative time, complications, post-operative hospital stay, conversion rate, functional and cosmetic results, and we compare them with conventional laparoscopic pyeloplasty. Conclusions: More reported series are necessary but it has been proved that minilap pyeloplasty is a reproducible and safe technique with excellent results

Pieloplastia por Minilap / Mini-laparoscopic pyeloplasty

Los continuos avances en el campo de la laparoscopia han ido siendo introducidos progresivamente en la cirugía urológica. Con el desarrollo de instrumental de menor tamaño nace la minilaparoscopia, buscando reducir el trauma abdominal y mejorar la cosmética de las cicatrices, obteniendo unos resultados similares o mejores a los logrados en la laparoscopia convencional. Objetivo: El objetivo es evaluar los resultados y la reproducibilidad de la pieloplastia por minilap. Método: Para ello se ha realizado una revisión de la literatura y una búsqueda bibliográfica en PubMed. Describimos la técnica quirúrgica realizada en el Hospital Universitario Marqués de Valdecilla, Santander (HUMV). Resultados: se encontraron más de 60 artículos que hacían referencia a la minilaparoscopia. Aunque a día de hoy son escasas las series reportadas de pieloplastia por minilap, estas ofrecen unos resultados excelentes. Analizamos los datos de tiempo quirúrgico, complicaciones, estancia hospitalaria, tasa de conversión, resultado funcional y cosmético, comparándolos con la pieloplastia laparoscópica convencional. Conclusiones: Aunque es necesario que se reporten más series, se ha demostrado que la pieloplastia por minilap es una técnica reproducible y segura, que otorga así mismo unos resultados excelentes

Continued progresses in the field of laparoscopy have been introduced in urological surgery. With the development of smaller instrumental minilaparoscopy was born seeking to reduce abdominal trauma and improve cosmetic scars, obtaining similar or better results than conventional laparoscopy. Objective: The objective of this paper is to evaluate the results and reproducibility of mini-laparoscopic pyeloplasty. Methods: A literature review and a bibliographic search in PubMed were performed. We describe the technique used in the "Hospital Marqués de Valdecilla" (HUMV), Santander (Spain). Results: 60 articles about mini-laparoscopy were found. Although there are few reported minilap pyeloplasty series, they offer excellent cosmetic and functional results. We analyze operative time, complications, post-operative hospital stay, conversion rate, functional and cosmetic results, and we compare them with conventional laparoscopic pyeloplasty. Conclusions: More reported series are necessary but it has been proved that minilap pyeloplasty is a reproducible and safe technique with excellent results

GRASSP: a spectrograph for the study of transient luminous events.

We present the main parameters, design features, and optical characterization of the Granada Sprite Spectrograph and Polarimeter (GRASSP), a ground-based spectrographic system intended for the analysis of the spectroscopic signature of transient luminous events (TLEs) occurring in the mesosphere of the Earth. It has been designed to measure the spectra of the light emitted from TLEs with a mean spectral resolution of 0.235 nm and 0.07 nm/px dispersion in the wavelength range between 700 and 800 nm.

Variability in Human Cone Topography Assessed by Adaptive Optics Scanning Laser Ophthalmoscopy.

PURPOSE: To assess between- and within-individual variability of macular cone topography in the eyes of young adults. DESIGN: Observational case series. METHODS: Cone photoreceptors in 40 eyes of 20 subjects aged 19-29 years with normal maculae were imaged using a research adaptive optics scanning laser ophthalmoscope. Refractive errors ranged from -3.0 diopters (D) to 0.63 D and differed by <0.50 D in fellow eyes. Cone density was assessed on a 2-dimensional sampling grid over the central 2.4 mm × 2.4 mm. Between-individual variability was evaluated by coefficient of variation (COV). Within-individual variability was quantified by maximum difference and root mean square (RMS). Cones were cumulated over increasing eccentricity. RESULTS: Peak densities of foveal cones are 168 162 ± 23 529 cones/mm(2) (mean ± SD) (COV = 0.14). The number of cones within the cone-dominated foveola (0.8-0.9 mm diameter) is 38 311 ± 2319 (COV = 0.06). The RMS cone density difference between fellow eyes is 6.78%, and the maximum difference is 23.6%. Mixed-model statistical analysis found no difference in the association between eccentricity and cone density in the superior/nasal (P = .8503), superior/temporal (P = .1551), inferior/nasal (P = .8609), and inferior/temporal (P = .6662) quadrants of fellow eyes. CONCLUSIONS: New instrumentation imaged the smallest foveal cones, thus allowing accurate assignment of foveal centers and assessment of variability in macular cone density in a large sample of eyes. Though cone densities vary significantly in the fovea, the total numbers of foveolar cones are very similar both between and within subjects. Thus, the total number of foveolar cones may be an important measure of cone degeneration and loss.

Glycosylated haemoglobin is markedly elevated in new and known diabetes patients with hyperglycaemic ketoacidosis.

BACKGROUND: Glycosylated haemoglobin (HbA1c) and random blood glucose are markers of chronic and acute hyperglycaemia respectively. OBJECTIVE: We compared HbA1c levels in ketoacidosis (DKA) occurring in known and newly diagnosed diabetes. METHODS: Retrospective review of medical records for 83 DKA admissions in 2008 and 2009 with results for HbA1c at presentation. RESULTS: There were 52 and 31 DKA admissions in known and newly diagnosed diabetes patients respectively. Fifty of the 83 DKA admissions were in females. The mean age (per admissions) and HbA1c of all admissions are 43.4 ± 20.3 years (n=83) and 12.7 ± 3.4 % (n=83) respectively. Mean HbA1c in known Type 1, known Type 2 and newly diagnosed diabetes patients were similarly very high: 12.4 ± 3.3 %, 12.5 ± 3.3 %, 13.1 ± 3.7 %; P = 0.6828. The HbA1c levels in newly diagnosed diabetes patients less than 30 years (likely Type 1 diabetes) and ≥ 30 years (likely Type 2 diabetes) were similar. There was a tendency to significantly positive correlation between blood glucose and HbA1c in new diabetes patients. CONCLUSIONS: In our setting, DKA is associated with markedly elevated HbA1c levels in known type 1, known type 2 and new onset diabetes.

Islet immunity and beta cell reserve of indigenous Black South Africans with ketoacidosis at initial diagnosis of diabetes.

OBJECTIVE: Islet immunity and beta cell reserve status were utilized to classify persons with ketoacidosis as the initial manifestation of diabetes. The clinical features of the various diabetes classes were also characterized. DESIGN: Prospective cross sectional study. SETTING: Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province, South Africa. PATIENTS: Indigenous Black South Africans with ketoacidosis as the initial manifestation of diabetes. INTERVENTIONS: Islet immunity and beta cell reserve were respectively assessed using serum anti-glutamic acid decarboxylase 65 (GAD) antibody and serum C-peptide after 1 mg of intravenous glucagon. OUTCOME MEASURES: Serum anti-GAD 65 antibody > or = 5 units/L and < 5 units/L, respectively defined anti-GAD 65 positive (A+) and negative (A-). Replete (beta+) and deplete (beta-) beta cell reserve were serum C-peptide after glucagon injection of > or = 0.5 ng/mL and < 0.5 ng/mL, respectively. The proportions of patients with A+beta-, A+beta+, A-beta- and A-beta+ and their clinical characteristics were determined. RESULTS: Of the 38 males and 33 females who participated in the study, patients were categorized in various classes: A-beta+, 46.5% (n=33/ 71); A-beta-, 26.8% (n=19/71); A+beta-, 22.5% (n=16/71); and A+beta+, 4.2% (n=3/71). The ages of the various classes were: 41.8 +/- 13.8 years for A-beta+ (n=33); 36.5 +/- 14.6 years for A-beta- (n=19); and 20.6 +/- 7.1 years for the combination of A+beta- with A+beta+ (n=19) (P<.0001, P<.0001 for the combination of A+beta- and A+beta+ vs A-beta+, P=.001 for the combination of A+beta- and A+beta+ vs A-beta-and P=.2 for A-beta- vs A-beta+. The clinical features of type 2 diabetes were most prevalent in A-beta+ class while the A+beta- and A+beta+ groups had the clinical profile of type 1A diabetes. CONCLUSIONS: Most of the indigenous Black South African patients with ketoacidosis as the initial manifestation of diabetes had islet immunity, beta cell reserve status and clinical profiles of type 2 diabetes.