CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
low-dose leptin +2 moredrug
Likely dose
low-dose leptin 30mgfrom record
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NCT01207934N/ACompleted
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Recombinant Human Leptin Therapy Effects on Insulin Action

Washington University School of Medicine·interventional·Posted Sep 23, 2010·Updated Jul 9, 2015

In Brief

A clinical study evaluating placebo, low-dose leptin, and 1 other intervention for Type Two Diabetes Mellitus. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType Two Diabetes Mellitus
CountriesUnited States
CollaboratorsAmgen, National Institutes of Health (NIH)

Timeline

N/ACompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2010
Enrollment StartAug 1, 1998
Primary CompletionJul 1, 2000
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago

Interventions

placebodietary

saline placebo

low-dose leptindrug

30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days

high-dose leptindrug

80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days