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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | saline placebo for fourteen days |
|
| low-dose leptin | Experimental | 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
|
| high-dose leptin | Experimental | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Dietary Supplement | saline placebo |
| |
| low-dose leptin |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. | 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. | baseline |
| Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo. | 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. | fourteen days |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Plasma Leptin Concentrations | Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood. | baseline |
| Post-treatment Plasma Leptin Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21411512 | Derived | 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. |
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Subjects were recruited from August 1998 to August 1999. All subjects were recruited via the Volunteer for Health system at Washington University School of Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | saline placebo for fourteen days |
| FG001 | Low-dose Leptin | 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
| FG002 | High-dose Leptin | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | saline placebo for fourteen days |
| BG001 | Low-dose Leptin | 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. | 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. | Posted | Jun 2011 | Mean | Standard Error | mmol/kg body weight/minute | baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | saline placebo for fourteen days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | 3143628708 | sklein@wustl.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020738 | Leptin |
| ID | Term |
|---|---|
| D054392 | Adipokines |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Drug |
30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
|
| high-dose leptin | Drug | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
|
plasma leptin levels after fourteen days ingestion of either leptin or placebo.
| fourteen days |
| BG002 | High-dose Leptin | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
80mg leptin daily for fourteen days |
|
|
| Secondary | Baseline Plasma Leptin Concentrations | Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood. | Posted | Jun 2011 | Mean | Standard Error | Micrograms/Liter | baseline |
|
|
|
| Primary | Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo. | 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. | Posted | May 2011 | Mean | Standard Error | mmol/kg body weight/minute | fourteen days |
|
|
|
|
| Secondary | Post-treatment Plasma Leptin Levels | plasma leptin levels after fourteen days ingestion of either leptin or placebo. | Posted | Jun 2011 | Mean | Standard Error | Micrograms/Liter | fourteen days |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Low-dose Leptin | 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days | 0 | 6 | 0 | 6 |
| EG002 | High-dose Leptin | 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days | 0 | 6 | 0 | 6 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups. |
| t-test, 2 sided |
| <0.01 |
a priori threshold for significance was p = 0.05. |
| 95 |
| No |
| Superiority or Other |