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Recombinant Human Leptin Therapy Effects on Insulin Action

This study has been completed.
Sponsor:
Collaborators:
Amgen
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01207934
First received: September 21, 2010
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Type Two Diabetes Mellitus
Dietary Supplement: placebo
Dietary Supplement: low-dose leptin
Dietary Supplement: high-dose leptin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Recombinant Human Leptin Therapy Effects on Insulin Action

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo. [ Time Frame: fourteen days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Baseline Plasma Leptin Concentrations [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.

  • Post-treatment Plasma Leptin Levels [ Time Frame: fourteen days ] [ Designated as safety issue: No ]
    plasma leptin levels after fourteen days ingestion of either leptin or placebo.


Enrollment: 18
Study Start Date: August 1998
Estimated Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
saline placebo for fourteen days
Dietary Supplement: placebo
saline placebo
Experimental: low-dose leptin
30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Dietary Supplement: low-dose leptin
30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Experimental: high-dose leptin
80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
Dietary Supplement: high-dose leptin
80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207934

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Amgen
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Klein, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01207934     History of Changes
Other Study ID Numbers: 98-0643
Study First Received: September 21, 2010
Results First Received: June 6, 2011
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
diabetes
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014