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Recombinant Human Leptin Therapy Effects on Insulin Action

NCT01207934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-07-09

Study results available
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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.

Conditions

  • Type Two Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

placebo

saline placebo

DRUG

low-dose leptin

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

DRUG

high-dose leptin

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Primary Completion
2000-07-31
Completion
2000-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01207934 on ClinicalTrials.gov