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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK058785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Amgen | INDUSTRY |
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.
Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.
Comparison: Leptin-treated group to placebo-treated group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| r-MetHuLeptin | Active Comparator | r-MetHuLeptin SubQ once daily |
|
| Placebo | Placebo Comparator | SubQ once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-metHuLeptin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Lipid Levels | At the end of each two month intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance (as Assessed by HOMA-IR) | At the end of each two month intervention | |
| Glycemia (as Assessed by Fasting Glucose) | At the end of each two month intervention | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35820631 | Derived | Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9. | |
| 21081243 | Derived | Magkos F, Brennan A, Sweeney L, Kang ES, Doweiko J, Karchmer AW, Mantzoros CS. Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study. Metabolism. 2011 Jul;60(7):1045-9. doi: 10.1016/j.metabol.2010.10.002. Epub 2010 Nov 16. |
| Label | URL |
|---|---|
| Click here for more information about the Mantzoros Research Group. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | r-MetHuLeptin First, Then Placebo | r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months. |
| FG001 | Placebo First, Then r-metHuLeptin | Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
| |||||||||||||
| Washout |
| |||||||||||||
| Intervention 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | r-MetHuLeptin SubQ once daily r-metHuLeptin/placebo then placebo/r-metHuLeptin |
| 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 | Serum Lipid Levels | Posted | Mean | Standard Error | mg/dl | At the end of each two month intervention |
|
|
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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 | r-MetHuLeptin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christos Mantzoros | BIDMC | 617-667-8630 | cmantzor@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D008060 | Lipodystrophy |
| D007333 | Insulin Resistance |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C122136 | recombinant methionyl human leptin |
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|
| Low Density Lipoprotein (LDL) Cholesterol Levels |
| At the end of each two month intervention |
| Free Fatty Acid (FFA) Levels | At the end of each two month intervention |
| Blood Pressure | percent change in mean blood pressure | At the end of each two month intervention |
| Fibrinogen | Fibrinogen | At the end of each two month intervention |
| Insulin Levels | At the end of each two month intervention |
| Lean Body Mass | lean body mass | At the end of each two month intervention |
| Viral Load | At the end of each two month intervention |
| CD4+ Lymphocytes | At the end of each two month intervention |
| Interleukin-6 (IL-6) Levels | At the end of each two month intervention |
| Hepatic Fat Content | At the end of each two month intervention |
| Click here for more information about Beth Israel Deaconess Medical Center. | View source |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Fasting leptin concentration | Mean | Standard Deviation | ng/ml |
|
| triglycerides | Mean | Standard Deviation | mg/dl |
|
| insulin | Mean | Standard Deviation | micro international units(μIU)/ml |
|
| glucose | Mean | Standard Deviation | mg/dl |
|
| hemoglobin A1c | Mean | Standard Deviation | % |
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| CD4 count | Mean | Standard Deviation | cells/μl |
|
| HIV viral load | Mean | Standard Deviation | copies/ml |
|
| Participants |
|
|
| Secondary | Insulin Resistance (as Assessed by HOMA-IR) | Posted | Mean | Standard Error | units on a scale | At the end of each two month intervention |
|
|
|
| Secondary | Glycemia (as Assessed by Fasting Glucose) | Posted | Mean | Standard Error | mg/dl | At the end of each two month intervention |
|
|
|
| Secondary | Low Density Lipoprotein (LDL) Cholesterol Levels | Posted | Mean | Standard Error | mg/dl | At the end of each two month intervention |
|
|
|
| Secondary | Free Fatty Acid (FFA) Levels | Posted | Mean | Standard Error | mEq/liter | At the end of each two month intervention |
|
|
|
| Secondary | Blood Pressure | percent change in mean blood pressure | Posted | Least Squares Mean | Standard Error | percentage change of mean blood pressure | At the end of each two month intervention |
|
|
|
| Secondary | Fibrinogen | Fibrinogen | Posted | Mean | Standard Error | mg/dL | At the end of each two month intervention |
|
|
|
| Secondary | Insulin Levels | Posted | Mean | Standard Error | mcIU/ml | At the end of each two month intervention |
|
|
|
| Secondary | Lean Body Mass | lean body mass | Posted | Mean | Standard Error | kg | At the end of each two month intervention |
|
|
|
| Secondary | Viral Load | Posted | Mean | Standard Error | copies/ml | At the end of each two month intervention |
|
|
|
| Secondary | CD4+ Lymphocytes | Posted | Mean | Standard Error | cells/mcl | At the end of each two month intervention |
|
|
|
| Secondary | Interleukin-6 (IL-6) Levels | Posted | Mean | Standard Error | pg/ml | At the end of each two month intervention |
|
|
|
| Secondary | Hepatic Fat Content | Posted | Mean | Standard Error | percentage of liver volume | At the end of each two month intervention |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | 0 | 7 | 0 | 7 |
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| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D050171 | Dyslipidemias |