Recombinant Human Leptin Therapy Effects on Insulin Action

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Amgen; National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• diagnosed with type 2 diabetes for less than ten years

• Body mass index 25 - 40

• hemoglobin A1C 7.5% - 12.0%

• fasting blood glucose between 90 and 240mg/dL

Exclusion Criteria:

• smoking

• pregnancy

• diabetes medications

• regular exercise (more than 3 hours per week)

• uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95