Skip to main content
OpenTrials
Completed

NCT Number: NCT01207934

Recombinant Human Leptin Therapy Effects on Insulin Action

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type Two Diabetes Mellitus Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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 weight loss-independent 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 (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

saline placebo

low-dose leptin

Drug

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

high-dose leptin

Drug

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

Primary outcomes

  1. Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.

    Time frame: baseline

    pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.

  2. Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.

    Time frame: fourteen days

    This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.

Secondary outcomes

  1. Baseline Plasma Leptin Concentrations

    Time frame: baseline

    Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.

  2. Post-treatment Plasma Leptin Levels

    Time frame: fourteen days

    plasma leptin levels after fourteen days ingestion of either leptin or placebo.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Amgen
  • National Institutes of Health (NIH)

Registry information

Acronym: Leptin

Important dates

Study start
1998
Primary completion
2000
Study completion
2000
First posted
Sep 23, 2010
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.