Clinical trial NCT01207934: Recombinant Human Leptin Therapy Effects on Insulin Action
Official title: Recombinant Human Leptin Therapy Effects on Insulin Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type Two Diabetes Mellitus
Keywords: diabetes
obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Amgen
name: National Institutes of Health (NIH)
First posted: 2010-09-23
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.
timeFrame: baseline
measure: Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.
timeFrame: fourteen days
Secondary outcomes:
measure: Baseline Plasma Leptin Concentrations
timeFrame: baseline
measure: Post-treatment Plasma Leptin Levels
timeFrame: fourteen days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
citation: Mittendorfer B, Horowitz JF, DePaoli AM, McCamish MA, Patterson BW, Klein S. Recombinant human leptin treatment does not improve insulin action in obese subjects with type 2 diabetes. Diabetes. 2011 May;60(5):1474-7. doi: 10.2337/db10-1302. Epub 2011 Mar 16.