Recombinant Human Leptin Therapy Effects on Insulin Action

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2000-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type Two Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo

saline placebo for fourteen days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

saline placebo

low-dose leptin

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

Group Type EXPERIMENTAL

low-dose leptin

Intervention Type DRUG

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

high-dose leptin

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

Group Type EXPERIMENTAL

high-dose leptin

Intervention Type DRUG

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

Interventions

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placebo

saline placebo

Intervention Type DIETARY_SUPPLEMENT

low-dose leptin

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

Intervention Type DRUG

high-dose leptin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No