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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003083 | U.S. NIH Grant/Contract | View source | |
| WU187 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function, quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life domains without adversely affecting immune or virologic status in people living with HIV.
Very few safe, effective, and novel treatments for metabolic syndromes that develop in HIV-infected people exist. These metabolic syndromes may increase cardiovascular disease risk in HIV-infected people and may reduce their quantity and quality of life. Practicing a yoga lifestyle intervention may provide a safe, effective and novel therapy for HIV metabolic syndromes, but this alternative form of therapy has not been tested in HIV-infected people with metabolic syndromes. In men and women with HIV-related metabolic syndromes, we will determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STOC | Placebo Comparator | Standard of care arm continues to receive standard of care treatment for HIV, but does not receive any new treatment/intervention or change in anti-HIV medications. Runs parallel to experimental group. At the end of this 16-wk control period, participants are invited to crossover into the experimental group |
|
| YOGA | Experimental | Yoga lifestyle intervention administered by certified yoga instructor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga lifestyle intervention | Behavioral | Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome is a metabolic parameter: insulin integrated area under the curve (AUC) during the oral glucose tolerance test. | Baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting lipid/lipoprotein levels. | Baseline and week 16 | |
| Body composition: visceral and subcutaneous adipose tissue areas (VAT, SAT), trunk/limb adipose ratio. | Baseline and week 16 | |
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Inclusion Criteria:
Additional Inclusion Criteria.
18-70 years old.
Plasma HIV RNA <15,000 copies/ml for previous 3months.
CD4 count >200 c/µL for previous 3 months.
Stable HIV RNA level and stable CD4 count for at least the past 3 months. Some HIV-infected people can accomplish this while not receiving HAART (eg. long term non-progressors) and will be included. But, most of the participants will be on a HAART regimen that includes either 2 NRTIs + NNRTI, or 2NRTIs + PI, or NRTI+NNRTI+PI
"Normal" blood chemistries for at least 1 month prior to enrollment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin E Yarasheski, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18227915 | Background | Innes KE, Vincent HK. The influence of yoga-based programs on risk profiles in adults with type 2 diabetes mellitus: a systematic review. Evid Based Complement Alternat Med. 2007 Dec;4(4):469-86. doi: 10.1093/ecam/nel103. | |
| 18566316 | Background | Schambelan M, Wilson PW, Yarasheski KE, Cade WT, Davila-Roman VG, D'Agostino RB Sr, Helmy TA, Law M, Mondy KE, Nachman S, Peterson LR, Worm SW; Working Group 5. Development of appropriate coronary heart disease risk prediction models in HIV-infected patients. Circulation. 2008 Jul 8;118(2):e48-53. doi: 10.1161/CIRCULATIONAHA.107.189627. Epub 2008 Jun 19. No abstract available. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006973 | Hypertension |
| D000163 | Acquired Immunodeficiency Syndrome |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of care | Other | Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary. |
|
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| Cardiovascular disease risk: Framingham 10-yr CVD risk calculation |
| Baseline and week 16 |
| Quality of life: SF36 MOS | Baseline and week 16 |
| Safety: CD4 count and plasma HIV RNA | Baseline and week 16 |
| 18453813 | Background | Bashir A, Laciny E, Lassa-Claxton S, Yarasheski KE. Magnetic resonance imaging for quantifying regional adipose tissue in human immunodeficiency virus-infected persons with the cardiometabolic syndrome. J Cardiometab Syndr. 2008 Spring;3(2):115-8. doi: 10.1111/j.1559-4572.2008.07595.x. No abstract available. |
| 18453805 | Background | Cade WT, Yarasheski KE. Cardiometabolic disease in the human immunodeficiency virus: the tip of the iceberg? J Cardiometab Syndr. 2008 Spring;3(2):77-8. doi: 10.1111/j.1559-4572.2008.07204.x. No abstract available. |
| 18427203 | Background | Mondy KE, de las Fuentes L, Waggoner A, Onen NF, Bopp CS, Lassa-Claxton S, Powderly WG, Davila-Roman V, Yarasheski KE. Insulin resistance predicts endothelial dysfunction and cardiovascular risk in HIV-infected persons on long-term highly active antiretroviral therapy. AIDS. 2008 Apr 23;22(7):849-56. doi: 10.1097/QAD.0b013e3282f70694. |
| Result | Mondy K, Cade WT, Reeds DN, Lassa-Claxton S, Bopp C, Tucker S, Yarasheski KE. Hatha/Ashtanga yoga intervention modestly improves cardiovascular disease (CVD) risk parameters in dyslipidemic HIV+ subjects with central adiposity(abstract). Antiviral Ther. 12 (suppl 2):L47, 2007. |
| 20059570 | Result | Cade WT, Reeds DN, Mondy KE, Overton ET, Grassino J, Tucker S, Bopp C, Laciny E, Hubert S, Lassa-Claxton S, Yarasheski KE. Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors. HIV Med. 2010 Jul 1;11(6):379-88. doi: 10.1111/j.1468-1293.2009.00801.x. Epub 2010 Jan 5. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D012897 | Slow Virus Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |