Lipid metabolism alterations in patients with gestational diabetes mellitus associated fetal macrosomia.

Fetal macrosomia is commonly associated with gestational diabetes mellitus (GDM) which may lead to various complications. It has been suggested that some other metabolites apart from maternal hyperglycemia are responsible for the genesis of macrosomia. Lipid metabolism changes in GDM patients having macrosomic fetuses were studied. A lipid tolerance test (10% Lipovenous solution) was performed in 14 GDM. Pre- and post-infusion plasma lipid levels and their elimination rates were measured and compared to the ones of 8 non diabetic control pregnant women. HbA1c, basal glucose and triglyceride levels were found to be higher in GDM group and significantly higher levels of triglycerides persisted throughout the infusion. FFA, glycerol and phospholipid levels increased following infusion in both groups without significant differences. Glucose, C-peptide and insulin levels remained unchanged after the infusion. Increased basal triglycerides with slowed triglyceride metabolism may be responsible for the fetal macrosomia in mild GDM patients whose fasting blood glucose are below 105 mg/dl. A better metabolic control that provides plasma lipid regulation as well as glucose control may forestall the occurrence of fetal macrosomia.

Safety and efficacy of [Lys(B28), Pro(B29)]-human insulin in patients with diabetes mellitus.

The primary objectives of this study were to assess the efficacy and safety of Lys(B28), Pro(B29) in the treatment of patients with diabetes mellitus and to compare Lys(B28), Pro(B29) to currently available regular insulin with respect to quality of life. This study was designed as an open-label, non-comparative one. The number of patients enrolled in the trial was 39. At Visit 1 (week 0), blood samples for fasting, 1- and 2-hour postprandial blood glucose, and HbA1c were taken. At Visit 2 (week 6) and Visit 3 (week 12), fasting, 1- and 2-hour postprandial blood glucose, and HbA1c levels were measured again. There was no significant change in HbA1c, fasting blood glucose and 1- and 2-hour postprandial blood glucose levels. The 1- and 2-hour postprandial blood glucose excursions decreased significantly from Visit 1 to Visit 3. There were no serious adverse events during the study. Half of the patients had less hypoglycemia with LysPro insulin, while 25% had an increase in episodes. Thirty percent of patients were more satisfied with LysPro insulin than with the short-acting insulin that they had previously used. In conclusion, LysPro therapy can be regarded as safe, since there were no unexpected adverse events and no changes in the usual physical parameters.

Antibiotic treatment for uncomplicated neuropathic forefoot ulcers in diabetes: a controlled trial.

To investigate the effect of oral antibiotics in purely neuropathic ulcers (Wagner grade 1-2, no osteomyelitis), a double blind placebo-controlled study was performed. Forty-four patients were enrolled and subjected to standard treatment with absolute pressure relief (half shoes), daily wound cleansing (topical disinfectant), sterile dressings (specialized nurse). Patients were randomized to an antibiotic (amoxicillin plus clavulanic acid), or placebo. The study was stopped when the antibiotic proved unsuitable according to swab result, or on clinical grounds (no improvement within 6 days of recruitment). Main outcome measure was the ulcer closing rate during 20 days, as assessed by standardized photographs. All ulcers except one were infected. Of the placebo group (n = 22), 2 patients had to be withdrawn within 6 days, versus 3 patients of the antibiotic-group (n = 22). In the placebo group, 10 ulcers were healed versus 6 ulcers in the antibiotic group (NS). Mean (95% CI) reduction in ulcer radius was 0.41 (0.21-0.61) mm day-1 in the placebo group versus 0.27 (0.15-0.39) mm day-1 in the antibiotic group (NS). In conclusion, there is no benefit from antibiotic treatment with amoxicillin plus clavulanic acid as a supplement to standard therapy in uncomplicated neuropathic foot ulcers, provided pressure relief is complete, and wound care is performed strictly supervised. However, a Type-II statistical error cannot be excluded in this small study.