N/A
N=18
Recombinant Human Leptin Therapy Effects on Insulin Action
Type Two Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01207934 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. — 14.3; 18.4; 16.7 mmol/kg body weight/minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- placebo (Dietary_supplement); low-dose leptin (Drug); high-dose leptin (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. |
14.3; 18.4; 16.7 | — |
| PRIMARY Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo. |
17.5; 20.7; 19.1 | >0.05 |
| SECONDARY Baseline Plasma Leptin Concentrations |
27; 24; 35 | — |
| SECONDARY Post-treatment Plasma Leptin Levels |
25; 76; 5024 | <0.01 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01207934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.