Effects of COVID-19 pandemic lockdown on gestational diabetes mellitus: A retrospective study.

OBJECTIVE: The objective of our study was to evaluate the impact of the lockdown period on the glycemic balance in patients with GDM. METHODS: A retrospective study in one center (Lille, France) compared two periods: the COVID-19 lockdown of 18 March 2020 to 7 May 2020 versus the same period during 2019. Glucose targets were defined by a capillary fasting glucose target < 5.1mmol/L and/or a 2-hour postprandial capillary glucose < 6.6 mmol/L. GDM control was defined as: good (< 20% of the glycemic values were not within the target range), acceptable (20 to 40% of the glycemic values were not within the target range) or poor (> 40% of the glycemic values were not within the target range). RESULTS: Two hundred twenty-nine patients were included in 2019 and 222 in 2020. The same mean number of capillary blood sugar tests was performed by the two groups. Postprandial blood sugar was significantly less well controlled in 2020, with a lower rate of good control (61.6% vs 69.4%) and higher rates of acceptable (24.7% vs 21.8%) and poor control (13.7% and 8.7%) (p < 0.05). Use of insulin therapy was significantly higher in 2020 compared with 2019 (47.7% and 36.2%, respectively; p < 0.05). CONCLUSION: Diabetes control was lower during the COVID-19 pandemic lockdown, even if follow-up was not impacted. This may be explained by reduced physical activity, modified dietary habits and anxiety during this period.

Gastrointestinal tolerance of erythritol-containing beverage in young children: a double-blind, randomised controlled trial.

BACKGROUND/OBJECTIVE: To determine gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children given as a single oral dose in a 250-ml non-carbonated fruit-flavoured beverage in between meals. This is a multicentre double-blind study with sequential design for multiple dose groups and randomised crossover for comparators of placebo vs dose. SUBJECTS/METHODS: A total of 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 children completed the study. Children were included in one of the four dose groups (5, 15, 20 or 25 g erythritol) and exposed randomly to only one single dose vs an isosweet sucrose placebo. After consumption in the clinic and an observation period, GI symptoms and stooling patterns were recorded during the next 48 h. RESULTS: Statistically significantly more episodes of diarrhoea and/or severe GI symptoms were observed in the 20 and 25 g groups compared with placebo, but not in the 5 and 15 g groups. Stool consistency, as measured by Bristol stool scale, was lower in the 15-, 20- and 25 g groups for the first 24 -h period, but not at later time points. Incidences of nausea, vomiting, borborygmi, excess flatus and abdominal pain were not significantly different from the placebo controls at all doses of erythritol. CONCLUSIONS: Rapid ingestion of up to and including 15 g (6% w/v) of erythritol in a beverage in between meals by young children aged 4-6 years was well tolerated. The no observed effect level for diarrhoea and/or severe GI symptoms was 15 g (0.73 g/kg body weight (bw)). Children appeared not to be more sensitive to the GI effects of erythritol than published for adults on a g/kg bw basis.

Outcome of twin pregnancies associated with glucose intolerance.

OBJECTIVES: There is little information about the impact of hyperglycaemia in twin pregnancies. The objective of our study was to evaluate the maternal, foetal and neonatal complications in patients with twin pregnancy and glucose intolerance defined by gestational diabetes mellitus and gestational mild hyperglycaemia. STUDY DESIGN: We performed a single-centre retrospective study. Screening for gestational diabetes was achieved by a two-step method. Patients were managed according to the French guidelines. After matching for age and body mass index, outcomes were compared in 177 patients with glucose intolerance and 509 controls. Macrosomia was defined as birth weight above the 90th percentile of gestational age adjusted for parity, foetal sex and maternal biometrics. RESULTS: Prevalence of glucose intolerance was 17.5% in our population. Complications of pregnancy and mode of delivery were similar between the two groups. Caesarean section was associated with age >35 years, vascular complications of pregnancy and non-cephalic presentation of the first twin. Rate of macrosomia was not different between the two groups. The only risk factor for macrosomia was a history of macrosomia in a previous pregnancy (odds ratio = 5.9, 95% confidence interval = 1.8-19.2). CONCLUSION: Twin pregnancies complicated by glucose intolerance were not associated with an increased risk of macrosomia or Caesarean section. Further studies should assess the value of screening gestational diabetes mellitus in twin pregnancies.

Digestive tolerance and postprandial glycaemic and insulinaemic responses after consumption of dairy desserts containing maltitol and fructo-oligosaccharides in adults.

BACKGROUND/OBJECTIVES: To evaluate the short-term digestive tolerance and glycaemic response of several associations of maltitol and short-chain fructo-oligosaccharides (scFOS) used to replace sugars (for example, dextrose) in foods. SUBJECTS/METHODS: Thirty-six healthy subjects aged 18-60 years were recruited for the study and 32 completed it. The subjects consumed six different mixtures of dextrose, maltitol and scFOS added in a chocolate dairy dessert at a dosage of 35 g. The test days were separated by 2-week washout periods. The subjects reported the intensity of four individual gastrointestinal (GI) symptoms, number of bowel movements and stool frequency for the 48 h following consumption of the dessert. A subgroup of 18 subjects also provided blood samples 2 h after intake to evaluate the postprandial glycaemic and insulinaemic responses. RESULTS: The composite score calculated from the intensity of flatulence, borborygmi, bloating and discomfort was significantly higher (P<0.0001) for all the desserts containing maltitol and/or scFOS than for the control dessert containing dextrose, but remains at the level of mild effects. The number of bowel movements was also slightly increased (P=0.0006) and the stools were softer (P=0.0045) for the first 24 h but not after (P=0.1373 and 0.5420, respectively). Blood glycaemic and insulinaemic responses were lower for all the sugar-free recipes containing maltitol and scFOS in comparison to the control one (P<0.0001). CONCLUSIONS: This study has shown that maltitol and scFOS can be used jointly when formulating sugar-free foods with the benefit to lower postprandial glycaemic response with only a small and transient increase in non-serious GI symptoms.

Efficacy and safety of the probiotic Lactobacillus paracasei LP-33 in allergic rhinitis: a double-blind, randomized, placebo-controlled trial (GA2LEN Study).

BACKGROUND/OBJECTIVES: An imbalance between Th1 and Th2 cells is involved in allergic rhinitis (AR) that may be improved by probiotics. To test the efficacy of the probiotic Lactobacillus paracasei subsp. paracasei LP-33, a double-blind, placebo-controlled, randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life. SUBJECTS/METHODS: Subjects with persistent AR, symptomatic during the grass pollen season, and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners (GPs). All received loratadine for 5 weeks. The primary end point was the improvement in Rhinitis Quality of Life (RQLQ) global score at the fifth week of LP-33 consumption compared with placebo (in addition to loratadine). Secondary end points included nasal and ocular symptoms (individual and total symptom scores), visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped. RESULTS: A total of 425 subjects were included. Using intent-to-treat analysis, the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group (P=0.0255, difference=-0.286 (95% confidence interval (CI): -0.536; -0.035)). No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups (P=0.1288, difference=-0.452 (95% CI: -1.036; 0.132)). Significant differences in ocular symptoms (RQLQ) were observed between groups (P=0.0029, difference=-0.4087 (95% CI: -0.6768; -0.1407)). CONCLUSIONS: This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H1-antihistamine. Whereas nasal symptoms had not changed, ocular symptoms had consistently improved.

Treating diabetes with islet transplantation: lessons from the past decade in Lille.

Type 1 diabetes (T1D) is due to the loss of both beta-cell insulin secretion and glucose sensing, leading to glucose variability and a lack of predictability, a daily issue for patients. Guidelines for the treatment of T1D have become stricter as results from the Diabetes Control and Complications Trial (DCCT) demonstrated the close relationship between microangiopathy and HbA1c levels. In this regard, glucometers, ambulatory continuous glucose monitoring, and subcutaneous and intraperitoneal pumps have been major developments in the management of glucose imbalance. Besides this technological approach, islet transplantation (IT) has emerged as an acceptable safe procedure with results that continue to improve. Research in the last decade of the 20th century focused on the feasibility of islet isolation and transplantation and, since 2000, the success and reproducibility of the Edmonton protocol have been proven, and the mid-term (5-year) benefit-risk ratio evaluated. Currently, a 5-year 50% rate of insulin independence can be expected, with stabilization of microangiopathy and macroangiopathy, but the possible side-effects of immunosuppressants, limited availability of islets and still limited duration of insulin independence restrict the procedure to cases of brittle diabetes in patients who are not overweight or have no associated insulin resistance. However, various prognostic factors have been identified that may extend islet graft survival and reduce the number of islet injections required; these include graft quality, autoimmunity, immunosuppressant regimen and non-specific inflammatory reactions. Finally, alternative injection sites and unlimited sources of islets are likely to make IT a routine procedure in the future.

Double-blind comparative trial with 2 antiregurgitation formulae.

BACKGROUND AND AIM: Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF). METHODS: A prospective, double-blind, randomized cross-over trial was performed for a 1-month period in 115 formula-fed infants (ages 2 weeks-5 months) comparing 2 ARF (ARF-1: nonhydrolyzed protein, locust bean gum; ARF-2: specific whey hydrolysate, locust bean gum, specially treated starch). The primary endpoint was the incidence of regurgitation. RESULTS: At inclusion, mean age was 9.1 weeks; anthropometric parameters did not differ between the groups. According to the intention-to-treat analysis, the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 (statistically significant difference between both ARF, P = 0.0091). The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 (P = 0.0265). There was no significant difference in stool frequency and consistency between both groups. CONCLUSIONS: The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations. ARF-2 was statistically more effective than ARF-1. Comparative trials enable the selection of the best therapeutic option.

Evaluation of digestive tolerance of a soluble corn fibre.

BACKGROUND: To assess consumers' acceptance of a new fibre, it is essential to evaluate its digestive tolerance after ingestion. We aimed to determine the tolerance of increasing dosages of Promitor™ Soluble Gluco Fibre (SGF; Tate&Lyle, Hoffman Estates, IL, USA) up to 70 g fibre per day using a validated gastrointestinal composite score. METHODS: A composite score of gastrointestinal tolerance integrating gastrointestinal symptoms, stool frequency and consistency was applied. To statistically validate this composite score, the gastrointestinal tolerance of inulin (10 g versus 20 g containing, respectively, 9 g versus 18 g of fibre) was assessed in 18 healthy volunteers in a randomised double-blind placebo-controlled cross-over study. Second, in a double-blind placebo-controlled cross-over study with 20 healthy volunteers, the gastrointestinal tolerance of SGF in both acute and 'spread over the day' conditions of consumption was assessed. RESULTS: By contrast to 10 g, 20 g of inulin demonstrated a significant difference in composite score compared to placebo [P < 0.001, difference = 7.6; 95% confidence interval (CI) = 3.8-11.3]. These values were considered as reference during the second study. In acute conditions, 40 g of SGF fibre was the highest (threshold) dose tested that indicates the digestive tolerance criteria (difference from placebo on the composite score <7.6 and upper limit of the 95% CI <11.3); this is twice the amount tolerated for inulin. In 'spread over the day' conditions, 65 g of SGF fibre was the threshold dose (P < 0.001, difference = 6.5; 95% CI = 3.4-9.5). CONCLUSIONS: The results of the present study demonstrate that 40 g of SGF fibre, when consumed as a single dose, and 65 g of SGF fibre, when consumed in multiple-doses, across the day are well-tolerated by healthy volunteers.

A double blind randomized controlled trial of a probiotic combination in 100 patients with irritable bowel syndrome.

OBJECTIVES: The purpose of this study was to evaluate the effects of a probiotic combination on symptoms in patients with irritable bowel syndrome (IBS). METHODS: We investigated the efficiency of a probiotic dietary supplement, containing four strains of lactic acid bacteria, on symptoms of IBS. One hundred and sixteen patients with IBS fulfilling the Rome II criteria were randomized in a parallel group, double-blind study to receive a placebo or a probiotic combination (1 x 10(10) cfu once daily) for four weeks. The symptoms that were monitored weekly included discomfort, abdominal pain, and stool frequency and quality. Quality of life was assessed before and at the end of the treatment using the SF36 and FDD-quality-of-life questionnaires. RESULTS: One hundred subjects completed the study (48 probiotic combination, 52 placebo). The probiotic combination was not superior to the placebo in relieving symptoms of IBS (42.6 versus 42.3% improvement). However, the decrease of abdominal pain between the first and the fourth week of treatment was significantly higher in probiotic treated patients (-41.9 versus -24.2%, P=0.048). Interesting findings from the IBS sub-groups were also observed such as a lower pain score at end point in patients with alternating bowel habits (P=0.023) and an increase of stool frequency in the constipated sub-group from the first week of probiotic treatment (P=0.043). CONCLUSIONS: The probiotic combination was not significantly superior to the placebo in relieving symptoms of IBS. Despite the apparent high placebo response, interesting findings from IBS sub-groups were observed in the field of abdominal pain and stool frequency.

[Fifteen practical questions concerning gestational diabetes]. / Quinze questions pratiques concernant le diabète gestationnel.

With a review of the current literature, a clarification on screening and management of gestational diabetes is hereby set out, within the frame of a Clinical Expert Series. According to the ethnic group, the prevalence varies from 1 to 14%. The treatment is based on dietary advice, insulin. The ACHOIS study demonstrates that the treatment of gestational diabetes significantly decreases perinatal complications (4 to 1%). The place of the oral treatment (glyburide) remains to be defined. In most countries, diagnosis rests on oral glucose test tolerance: Sullivan 50 g glucose test (1 hour) and 100 g test of glucose if positive (3 hours); WHO 75 g test (2 hours). The screening can be systematic or only on risk factors (wide variations between studies). Screening of gestational diabetes is required because its management improves pregnancy outcomes. Despite this, there is no consensus on the strategy of screening and diagnosis.

[Pathophysiology of gestational diabetes]. / Physiopathologie du diabète gestationnel.

During pregnancy, a number of maternal metabolic changes occur early and continue throughout pregnancy which help optimize the transfer of nutrients to the fetus. During normal pregnancy, there are a decrease in insulin sensibility which is physiological, progressive and reverse. For glucose tolerance to be maintained in pregnancy it is necessary for maternal insulin secretion to increase sufficiently to counteract the fall in insulin sensitivity. The metabolic characteristic of women with gestational diabetes is insufficient insulin secretion to counteract the pregnancy related fall in insulin sensitivity. There are a lot of factors that could explain the mechanism of insulin secretion and insulin sensitivity during normal pregnancy and gestational diabetes mellitus. Although glucose tolerance normalizes shortly after pregnancy with gestational diabetes in the majority of women, the risk of developing overt diabetes, especially type 2 diabetes is markedly increased. The mechanisms which could explain gestational diabetes are the same as type 2 diabetes mellitus. We could speculate that these two diseases are identical for alterations in carbohydrate metabolism, but at different stages.

[Maternal and fetal outcome]. / Devenir de la mère et de l'enfant.

Gestational diabetes, a glucose tolerance disorder of variable severity which occurs or is diagnosed for the first time during pregnancy, constitutes a public health problem because of its frequency (1 to 6% of all pregnancies) and its short-or long term consequences for the foetus and/or the mother. There is as yet still no consensus concerning screening and diagnosis criteria, therapeutic management and the reality of the disease. This population is a high risk population of diabetes mellitus, especially of type 2 diabetes. We could think that the introduction of specific prevention programs in this group could delay or avoid diabetes mellitus and its complications. The mechanisms which could explain gestational diabetes are the same as type 2 diabetes mellitus. We could speculate that these two diseases are identical for alterations in carbohydrate metabolism, but at different stages. It has been reported that the offspring of gestational diabetics mothers are at risk of obesity and glucose intolerance. Therapeutic management of the mother and/or the offspring should be better defined. The screening for gestational diabetes provides an opportunity of identify a large population of women and children at risk of diabetes. It should be possible to avoid diabetes mellitus by specific therapeutic programs in these populations.

[Are the principles of treatment of chronic osteitis applicable to the diabetic foot?]. / Les principes du traitement de l'ostéite chronique sont-ils applicables au pied diabétique?

OBJECTIVE: The interest of the management of bone infections in the diabetic foot, inspired by the recommendations for the treatment of chronic osteitis, was assessed in this study. METHODS: Twenty bone infections in 17 diabetic patients with moderate to mild infections of the feet were confirmed by the results of X-ray and/or scintigraphic studies and bone surgery biopsy cultures revealing one or more bacteria sensitive to standard osteitis treatment (rifampicine + fluoroquinolone). The patients had received this treatment per os for a median duration of 6 months (3 to 10 months). Clinical follow-up was carried out during a consultation at 1, 3 and 6 months during treatment and then by telephone every six months after the end of treatment. Clinical success was defined as the disappearance of any local sign of infection and by the absence of relapse during the post-treatment follow-up period. The evolution of the bone infection was also assessed by the results of a control conducted 3 to 6 months after initiation of the antibiotic treatment. RESULTS: At the end of the treatment, all signs of infection had disappeared in 15/17 patients (88.2%) and no relapse had occurred in 14 (82.3%) patients at the end of a median post-treatment period of 22 months (12 to 41 months). Resection of necrotic bone was performed at the same time as the bone biopsy in 2 patients. The median duration of hospitalisation was of 14 days (3 to 53 days). During the study, a multi-resistant germ was isolated in 4 patients (1 Pseudomonas aeruginosa, 3 Staphylococcus aureus). During the post-treatment follow-up, 3 patients dies from causes unrelated to the infection treated. No serious adverse event was reported during the study. DISCUSSION: The results of this pilot study support the rationale of applying the treatment regimens of chronic osteitis to diabetic lesions of the feet, but are only applicable to comparable patients presenting with non-severe lesions of the feet. Moreover, the use of antibiotics with potent selection of resistance such as rifampicine and fluoroquinolone, requires that bone biopsies be taken, which is not easy in all the diabetic foot care centres. We are presently conducting a study to identify the sub-populations of diabetic patients who could benefit from such treatment.

Rifampicin-ofloxacin oral regimen for the treatment of mild to moderate diabetic foot osteomyelitis.

Seventeen diabetic patients with moderate to mild foot lesions associated with 20 osteomyelitic bones diagnosed by both bone scan and bone biopsy received rifampicin plus ofloxacin for a median duration of 6 months. Cure was defined as disappearance of all signs and symptoms of infection at the end of the treatment and absence of relapse during follow up. At the end of the treatment period, cure was achieved in 15 patients (88.2%) and was maintained in 13 patients (76.5%) at the end of an average post-treatment follow-up of 22 months. No serious drug-related adverse events were recorded.

Technologies for implementation of quality assurance in the clinical laboratory.

To face the rapid evolution of the clinical laboratory activity from sample analysis towards an in-vitro diagnostic network, a Total Quality Management system must be implemented by laboratory professionals. Technological advances make it possible to introduce new tools and techniques for many issues surrounding the analytical process, as has happened for analysis automation and laboratory management. Preanalytical steps should benefit from extended traceability, using new identification devices such as electronic labels. This may promote the improvement of sample handling in this phase, such as during transportation or centrifugation. Another field is the expansion of metrology. Many factors can now easily be controlled in the clinical laboratory. New reliable automated systems are available to evaluate the performance of pipetting devices. Autonomous miniaturized recorders and probes connected to monitoring softwares allow traceable temperature monitoring. In this paper, some examples are presented to illustrate how technical solutions can support the implementation of Quality Assurance in the clinical laboratory.

New tools for laboratory design and management.

The clinical laboratory is changing from a place of activity based on sample analysis to an in vitro diagnostic network. To convince our team, partners, and administrators, we need new comprehensive tools to define a strategy with limited risk of failure or conflicts. Specific quality goals should be established before choosing automated tools for sample handling, analytical systems, laboratory information systems, communication systems, or advanced technologies. A system approach maps and simplifies the process, based more on a functional study than on classical disciplines. A customer-supplier approach establishes the requirements between partners either inside or outside the laboratory. The quality system must be a management tool, linking samples, tasks, information, and documents. Quantitative simulation modeling explores different automation alternatives and their impact on laboratory workflow. Finally, integration of results in interactive semirealistic simulation tools for laboratory design or reengineering can be used as communications tools to involve laboratory professionals in the change of their practice.

Gestational diabetes mellitus and HLA class II (-DQ, -DR) association: The Digest Study.

Gestational diabetes mellitus (GDM) and impaired glucose tolerance during pregnancy (IGT) are associated with an increased risk of perinatal morbidity and then further development of diabetes among 30-50% of affected women. This is a real public health problem that deserves investigation of phenotypic and genotypic predisposing markers. However, the involvement of genetic background in GDM and IGT remains unclear. In particular, association with HLA class II polymorphism has been poorly studied and has produced conflicting results. In attempt to clarify these discrepancies, we investigated HLA class II polymorphism in 95 GDM and 95 IGT women from the north of France using DNA amplification followed by restriction enzyme digestion (PCR-RFLP). Ninety-five pregnant women with normal glucose tolerance (NGT) were chosen as a control reference group. The distribution of HLA class II polymorphism was not found to be significantly different between GDM, IGT and NGT samples. In particular, we did not find any significant variation of DRB1*03 and DRB1*04 allele frequencies between these three groups. These data provide further evidence that insulin-dependent diabetes mellitus (IDDM) HLA class II susceptibility alleles cannot serve as genetic markers for susceptibility to glucose intolerance during pregnancy. However, GDM and IGT were not equivalent to the NGT control group and presented particular HLA patterns. In particular, we observed an increase of the DRB1*0701-DQA1*0201-DQB1*02 haplotype in GDM women (P = 0.02; Pc not significant) and an increase of DRB1*0101-DQA1*0101-DQB1*0501 and DRB1*1302-DQA1*0102-DQB1*0604 haplotypes in the IGT group (P = 0.02 and 8 x 10(-3), respectively; Pc not significant). In contrast, we found a decrease in the DRB1*1101 allele in IGT samples (P = 0.03; Pc not significant) and a decrease of DRB1*1103-*1104 alleles in the GDM group (P = 9 x 10(-3); Pc not significant). Although these findings are only descriptive, it points out the genetic heterogeneity of glucose intolerance during pregnancy.