Recombinant Human Leptin Therapy Effects on Insulin Action
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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 |
- 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.
- 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 |
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 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013