Recombinant Human Leptin Therapy Effects on Insulin Action

Completed · Not applicable · Has a placebo group

Conditions studied: Type Two Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01207934

Run by

Washington University School of Medicine

People needed

18

Starts

1998-08-01

Expected to finish

2000-07-01

Last updated by the study team

2015-07-09

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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