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The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.
The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition, all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to follow guidelines for a healthy level of physical activity. In the second 6-months of the study, all volunteers will continue to receive lifestyle modification and all will receive eplerenone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone and Lifestyle | Experimental | First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months) |
|
| Placebo and Lifestyle | Placebo Comparator | First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone and lifestyle | Drug | eplerenone 50mg by mouth daily as well as lifestyle counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Stimulated Glucose Uptake | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Adipose Tissue | 6 months | |
| Liver Fat | 6 months | |
| Intramyocellular Lipid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34909518 | Derived | Srinivasa S, deFilippi C, Fitch KV, Iyengar S, Shen G, Burdo TH, Walpert AR, Thomas TS, Adler GK, Grinspoon SK. Evaluation of Mineralocorticoid Receptor Antagonism on Changes in NT-proBNP Among Persons With HIV. J Endocr Soc. 2021 Nov 19;6(1):bvab175. doi: 10.1210/jendso/bvab175. eCollection 2022 Jan 1. | |
| 29659888 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eplerenone and Lifestyle | First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months) Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling |
| FG001 | Placebo and Lifestyle | First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification placebo and lifestyle: placebo pill daily and lifestyle counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eplerenone and Lifestyle | First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months) Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Insulin Stimulated Glucose Uptake | Posted | Median | Inter-Quartile Range | mg/min per μIU/ml | 6 months |
|
6 months
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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 | Eplerenone and Lifestyle | First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months) Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Creatinine | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven K. Grinspoon | Massachusetts General Hospital | 6177249109 | sgrinspoon@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2016 | May 16, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| placebo and lifestyle | Other | placebo pill daily and lifestyle counseling |
|
| 6 months |
| Flow Mediated Vasodilation | 6 months |
| Potassium | 6 months |
| Hemoglobin A1c | 6 months |
| C-Reactive Protein | 6 months |
| Plasminogen Activator Inhibitor 1 | 6 months |
| Adiponectin | 6 months |
| Markers of Systemic Inflammation | IL-6 | 6 months |
| Markers of Immune Activation | MCP-1 | 6 months |
| Srinivasa S, Fitch KV, Wong K, O'Malley TK, Maehler P, Branch KL, Looby SE, Burdo TH, Martinez-Salazar EL, Torriani M, Lyons SH, Weiss J, Feldpausch M, Stanley TL, Adler GK, Grinspoon SK. Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2376-2384. doi: 10.1210/jc.2018-00330. |
| BG001 |
| Placebo and Lifestyle |
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification placebo and lifestyle: placebo pill daily and lifestyle counseling |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insulin Stimulated Glucose Uptake | Insulin stimulated glucose uptake at steady state using the euglycemic hyperinsulinemic clamp technique normalized to insulin and lean body mass. | Endpoint could not be obtained. Subject was unable to complete the procedure. | Median | Inter-Quartile Range | mg/min per μIU/ml |
|
| Visceral Adipose Tissue | Abdominal visceral fat obtained by MRI. | Endpoint could not be obtained. Subjects could could not complete the procedure. | Median | Inter-Quartile Range | cm^2 |
|
| Liver Fat | Intrahepatic lipid obtained by MRS. | Endpoint could not be obtained. Subjects could not complete the procedure. | Median | Inter-Quartile Range | percentage of intrahepatic lipid |
|
| Intramyocellular Lipid | Intramyocellular lipid of the tibialis anterior muscle obtained by MRS. | Endpoint could not be obtained. Subjects could not complete the procedure. | Median | Inter-Quartile Range | percentage of intramyocellular lipid |
|
| Flow Mediated Vasodilation | Flow mediated vasodilation obtained at the brachial artery. | Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed. | Median | Inter-Quartile Range | percentage of maximum change |
|
| Potassium | Mean | Standard Deviation | mEq/L |
|
| Hemoglobin A1c | Median | Inter-Quartile Range | percentage |
|
| C-reactive Protein | Endpoint could not be evaluated. Sufficient sample was not obtained. | Median | Inter-Quartile Range | mg/L |
|
| Plasminogen Activator Inhibitor 1 | Endpoint could not be obtained. Sufficient sample was not obtained. | Mean | Standard Deviation | ng/mL |
|
| Adiponectin | Endpoint could not be evaluated. Sufficient sample was not obtained. | Median | Inter-Quartile Range | pg/mL |
|
| Markers of Systemic Inflammation | IL-6 | Endpoint could not be evaluated. Sufficient sample was not obtained. | Median | Inter-Quartile Range | pg/mL |
|
| Markers of Immune Activation | MCP-1 | Endpoint could not be evaluated. Sufficient sample was not obtained. | Mean | Standard Deviation | pg/mL |
|
|
|
|
| Secondary | Visceral Adipose Tissue | Posted | Median | Inter-Quartile Range | cm^2 | 6 months |
|
|
|
|
| Secondary | Liver Fat | Posted | Median | Inter-Quartile Range | percentage of intrahepatic lipid | 6 months |
|
|
|
|
| Secondary | Intramyocellular Lipid | Posted | Median | Inter-Quartile Range | percentage of intramyocellular lipid | 6 months |
|
|
|
|
| Secondary | Flow Mediated Vasodilation | Posted | Median | Inter-Quartile Range | percentage of maximum change | 6 months |
|
|
|
|
| Secondary | Potassium | Posted | Mean | Standard Error | mEq/L | 6 months |
|
|
|
|
| Secondary | Hemoglobin A1c | Posted | Median | Inter-Quartile Range | percentage | 6 months |
|
|
|
|
| Secondary | C-Reactive Protein | Posted | Median | Inter-Quartile Range | mg/L | 6 months |
|
|
|
|
| Secondary | Plasminogen Activator Inhibitor 1 | Posted | Mean | Standard Error | ng/mL | 6 months |
|
|
|
|
| Secondary | Adiponectin | Posted | Median | Inter-Quartile Range | pg/mL | 6 months |
|
|
|
|
| Secondary | Markers of Systemic Inflammation | IL-6 | Posted | Median | Inter-Quartile Range | pg/mL | 6 months |
|
|
|
|
| Secondary | Markers of Immune Activation | MCP-1 | Posted | Mean | Standard Error | pg/mL | 6 months |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | Placebo and Lifestyle | First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification placebo and lifestyle: placebo pill daily and lifestyle counseling | 0 | 21 | 0 | 21 | 11 | 21 |
| Dizziness | Cardiac disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal Bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other Infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary Symptoms | Renal and urinary disorders | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Mood Symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|