Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial.

Objective: To assess whether 4 week's use of a continuous glucose monitoring (CGM) system improves glucose control, treatment satisfaction or health status, as compared to intensified conventional finger-prick measurements (ICFM) in patients with type 1 diabetes mellitus (DM1). Method: Thirty patients suffering from DM1 for more than three years and treated with either insulin pumps or multiple daily insulin injections, were included in a randomised controlled cross-over trial. They were Caucasians of both genders, between 18 and 50 years, and had moderately well controlled diabetes. The participants performed either ICFM or CGM for 4 weeks, followed by an 8 week's observation period. Thereafter they were crossed over to the opposite intervention. HbA(1c) , hypoglycaemic episodes, treatment satisfaction and health status were assessed at all meetings, although HbA(1c) was the primary endpoint. Results: At inclusion mean HbA(1c) was 7.8 ± 0.9 %. The mean change in HbA(1c) was -0.2 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM periods, accordingly (p = 0.91). The mean changes in HbA(1c) during the combined treatment and observation periods were -0.1 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM period, accordingly (p = 0.86). The frequency of severe hypoglycaemic episodes, treatment satisfaction and health status was also equal between the two interventions. No adverse events were observed.

Favorable long-term effects of growth hormone replacement therapy on quality of life, bone metabolism, body composition and lipid levels in patients with adult-onset growth hormone deficiency.

OBJECTIVE: The goal of growth hormone (GH) replacement is to improve quality of life (QoL) and prevent the long-term complications of GH deficiency (GHD). Thirty-nine patients with adult-onset GH deficiency (AOGHD) who had originally participated in a randomized placebo-controlled crossover study involving treatment with either GH or placebo for nine months were enrolled in an open, 33-month follow-up study of the effects on QoL as well as bone and metabolic parameters. METHODS: GH replacement was dosed individually to obtain IGF-I concentrations that were within the upper part of the normal range for age (mean+1SD). The variables were assessed on five occasions during the study. RESULTS: QoL, as assessed by the sum scores of HSCL-58, AGHDA, physical activity (KIMS question 11) and the dimension vitality in SF-36, improved. Markers of bone formation and resorption remained increased throughout the study period. Bone mineral area (BMA), bone mineral content (BMC) and bone mineral density (BMD) increased in both the lumbar (L2-L4) spine and total body. BMC and BMD increased in the femur. Hypogonadal women however, showed reduced bone mass during the study period. The changes in body fat mass (BFM) and lean body mass (LBM) were sustained throughout the long-term treatment (BFM -2.18 (+/-4.87) kg LBM by 2.01(+/-3.25) kg). Low-density lipoprotein cholesterol (LDL-C) levels were reduced by 0.6 (+/-1.1) mmol/l, and high-density lipoprotein cholesterol (HDL-C) levels increased by 0.2 (+/-0.3) mmol/l. No changes were observed in body weight, fasting total cholesterol, triglycerides, HbA1c and plasma glucose. Mean fasting insulin levels increased significantly from 110 pmol/l to 159 pmol/l, p<0.02. CONCLUSION: Long-term replacement of growth hormone in patients with AOGHD induces favorable effects on QoL as well as bone and metabolic parameters. An increase in insulin levels is also noteworthy.

Metformin has no major effects on glucose homeostasis in pregnant women with PCOS: results of a randomized double-blind study.

OBJECTIVE: Previous non-randomized and uncontrolled studies indicate major metformin effects on glucose homeostasis in pregnant women with polycystic ovary syndrome (PCOS). We investigated metformin effects on glucose homeostasis in a prospective controlled study. MATERIAL AND METHODS: Forty pregnant women with PCOS and without known diabetes mellitus were included in the first trimester and randomized to either metformin 850 mg twice daily or placebo. Outcome measures were fasting glucose and insulin at inclusion and changes to pregnancy weeks 19, 32 and 36 and 2 h glucose levels during a 75 g oral glucose tolerance test (OGTT) carried out at inclusion and pregnancy weeks 19 and 32. Insulin resistance (HOMA-IR) and beta-cell function (HOMA-beta) were calculated using the homeostasis assessment model. RESULTS: At inclusion, 2 h glucose levels during OGTT were higher in the placebo group (7.14 versus 6.03 mmol/L; p = 0.012). Accordingly, 6 out of 22 in the metformin group versus 2 out of 18 women in the placebo group (p = 0.21) had gestational diabetes mellitus at inclusion. At gestational weeks 19 and 32, 2-h plasma glucose levels were equal between the groups. The total proportion of women with gestational diabetes did not differ between the groups, nor did any of the other indices of glucose metabolism and insulin resistance. CONCLUSIONS: Metformin seems to be without major effects on glucose homeostasis in pregnant women with PCOS.

Metformin reduces pregnancy complications without affecting androgen levels in pregnant polycystic ovary syndrome women: results of a randomized study.

BACKGROUND: Investigation of a possible effect of metformin on androgen levels in pregnant women with polycystic ovary syndrome (PCOS). METHODS: A prospective, randomized, double-blind, placebo-controlled pilot study was conducted. Forty pregnant women with PCOS received diet and lifestyle counselling and were randomized to either metformin 850 mg twice daily or placebo. Primary outcome measures were changes in serum levels of dehydroepiandrosterone sulphate, androstenedione, testosterone, sex hormone-binding globulin, and free testosterone index. Secondary outcome measures were pregnancy complications and outcome. Two-tailed t-tests and chi2-tests were used. RESULTS: Maternal androgen levels were unaffected by metformin treatment in pregnant women with PCOS. While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication, seven of the 22 (32%) women experienced severe complications in the placebo group (P = 0.01). CONCLUSIONS: Metformin treatment did not reduce maternal androgen levels in pregnant women with PCOS. In the metformin-treated group we observed a reduction of severe, pregnancy and post-partum complications. Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period.

Cardiovascular disease and risk factors in persons with type 2 diabetes diagnosed in a large population screening: the Nord-Trøndelag Diabetes Study, Norway.

OBJECTIVE: To study cardiovascular status and risk factors in persons with newly diagnosed type 2 diabetes and controls in a large population. DESIGN: Case-control study. SETTING: Population screening. SUBJECTS: The screening of 74 499 individuals (88.1%), aged 20 years and older, in Nord-Trøndelag County, Norway, during 1984-86 detected 428 persons with undiagnosed diabetes according to the 1980 WHO criteria, of whom 205 attended a clinical follow-up examination assessing cardiovascular status and risk factors. METHODS: For each of 205 cases, one control person matched by age and sex underwent the same clinical examination. Lipids, body mass index, waist/hip ratio, blood pressure, pulse rate, blood pressure medication, kidney function, cardiovascular disease, family history and lifestyle were recorded. RESULTS: At the screening prior to the diagnosis of diabetes, those with diabetes reported poorer general health, less physical activity, more siblings with diabetes and more frequent use of antihypertensive medication. They had higher body mass index, systolic and diastolic blood pressure and pulse rate compared with controls. At the clinical evaluation, diabetics had higher urine albumin levels, increased waist/hip ratio, and higher total cholesterol/HDL cholesterol ratios than the controls. They also reported a greater incidence of angina pectoris and had more ECG changes. CONCLUSIONS: Diabetics presented with more cardiovascular risk factors, angina pectoris and ECG changes than the controls, and they had an established metabolic syndrome more often than controls. These results suggest that prevention of cardiovascular disease in diabetics requires earlier diagnosis of the diabetes.

Omega-3 fatty acids: essential fatty acids with important biological effects, and serum phospholipid fatty acids as markers of dietary omega 3-fatty acid intake.

Serum phospholipid eicosapentaenoic (PL-EPA) and docosahexaenoic acid (PL-DHA) concentrations are associated with the dietary intake of omega 3 fatty acids. PL-EPA and PL-DHA concentrations measured 4 y apart in 211 diabetic patients were highly correlated, with Spearman correlation coefficients of 0.49 (p = 0.0001) and 0.64 (p = 0.0001), respectively. PL-DHA was positively associated with Bayley psychomotor and mental developmental indexes (PDI and MDI, respectively) in preterm infants. Using multiple-regression analysis, 64% (R2 = 0.639; p = 0.0001) of PDI variance was explained by 1/DHA and weight at 1 y, whereas 82% (R2 = 0.816; p = 0.0001) of MDI variance was explained by weight at 1 y, Apgar score, 1/DHA, and 1/EPA. 1/DHA was negatively correlated with PDI and MDI, whereas 1/EPA was positively correlated with MDI. The results suggest that infant formulas should contain preformed DHA, and that a too-high supply of EPA in addition to DHA might be harmful in preterm infants.

Bone mineral and hormone status in paraplegics.

Nineteen men who had suffered permanent paraplegia a median of 4 years previously were studied. Eight also had varying degrees of neurological deficit of the upper extremities. Bone mineral, biochemical and hormonal values were compared to those in an age-matched control group in order to detect evidence of systemic osteopenia. There were very considerable individual variations in bone mineral density (BMD) deficits among patients compared to controls, probably partly due to methodological problems. Significant BMD deficits were found in the metaphysis (45%) and diaphysis (26%) of the tibia, while the deficit of the distal forearm was barely significant for the group as a whole. There was a negative correlation between time since injury and degree of BMD deficit in the lower extremity. Those with neurological affection of the upper extremities had a greater BMD deficit of their arms than those with neurologically intact arms. It was concluded that osteopenia in paraplegics is largely confined to the paralysed extremities, and thus not systemic. Serum alanine aminotransferase, phosphate, follicle stimulating hormone, and free androgen index (testosterone/sex hormone binding globulin) were mainly within normal limits, but significantly higher in paraplegics than in controls. Osteopenia in these patients is thus not due to gonadal dysfunction.

Hormonal and biochemical disturbances in Down's syndrome.

Clinical and laboratory endocrine variables in 29 adult institutionalized patients with Down's syndrome were compared with those of matched controls consisting of other mentally retarded patients from the same institution. Of the clinical variables, testes volume and body height were significantly lower in patients with Down's syndrome than in control patients. The thyroid function tests documented a higher average TSH level in Down's syndrome than in other mentally retarded patients. However, there was no clear-cut correlation between TSH and thyroid hormone levels. The data indicate that there is a tendency towards primary thyroid dysfunction in Down's syndrome. In addition, there is some evidence indicating a relative failure of TSH secretion. In male patients, estradiol was elevated compared to controls. FSH and LH also seemed slightly higher in the study group, but the differences only reached statistical significance when patients on chronic medication were omitted. Prolactin was significantly greater in the Down's syndrome patients than in the controls, both over the entire sample and in the subgroup of men with Down's syndrome, with P-values of around 0.001. The elevation of prolactin was not due to medication and did not correlate to thyroid function or difficulties during blood sampling. In females, the difference was not statistically significant. Laboratory tests that may be associated with endocrine disease or might indicate disease which could influence the endocrine status, were also included in this study. Compared with the controls, ESR, creatinine and uric acid levels were higher in Down's syndrome patients, while albumin was lower, all with P-values lower than 0.001. Vitamin B12 was moderately lower in Down's syndrome patients than in controls (P less than 0.05).

n-3 fatty acids in old age.

Plasma phospholipid fatty acid concentrations have been measured in 735 individuals 12-89 years old. The absolute concentrations of palmitic, stearic, oleic, linoleic, dihomo-gammalinolenic, arachidonic, eicosapentaenoic, docosapentaenoic and docosahexaenoic acids increased from the third to the fifth decade of life, thereafter remaining fairly constant into the ninth decade. Alpha-linolenic acid showed no change. When expressed as g 100 g-1 fatty acids, palmitic, stearic, and linoleic acid decreased from the third to the fifth decade of life, dihomo-gammalinolenic and arachidonic acid remained unchanged, while the relative concentrations of long-chain n-3 fatty acids increased in a similar manner as when expressed in absolute concentrations. The results indicate that old age in itself has only a minor impact on the availability of n-3 fatty acids in the elderly. Factors such as living area and eating habits probably have a much more profound effect on their availability, also in old age.