Yoga for the Management of HIV-Metabolic Syndromes

NCT00627380 | Completed Phase 4 DMC

• 2 other identifiers: R21AT003083WU187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; HIV Metabolic Cardiovascular Syndrome; HIV Lipodystrophy; HIV Metabolic Syndromes; Hypertension

Keywords

HIV; AIDS; insulin resistance; diabetes; dyslipidemia; visceral adiposity; subcutaneous adipose wasting; cardiovascular disease; hypertension; endothelial function; quality of life; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

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

Other: Standard of care

YOGA

EXPERIMENTAL

Yoga lifestyle intervention administered by certified yoga instructor.

Behavioral: Yoga lifestyle intervention

Interventions

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.

Also known as: Hatha yoga, Ashtanga yoga

YOGA

Standard of care OTHER

Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.

Also known as: Observation control group

STOC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected volunteers must have dyslipidemia (fasting serum LDL-cholesterol \>100mg/dL, or
• triglycerides \>200mg/dL, or
• HDL-cholesterol \<40mg/dL (men) or \<50mg/dL (women), or
• impaired glucose tolerance (fasting blood glucose 100-140mg/dL or
• fasting insulin 13-45µU/mL or 2hr glucose during the oGTT 140-200mg/dL),or
• central adiposity (waist circumference \>102 cm (40inches in men) or \>88cm (35inches in women)
• The purpose is to identify and enroll participants with a clear proatherogenic lipid profile
• increased CVD risk
• abdominal adiposity, and fasting glucose intolerance or insulin resistance
• but not type 2 diabetics who have normalized their blood sugars using glucose-lowering agents. If a type 2 diabetic uses a glucose-lowering medication, but they are still insulin resistant/glucose intolerant (by above criteria), they are eligible to participate, because we are testing the added benefits of yoga therapy on a defined dysmetabolic syndrome in participants who are stable on the standard-of-care for these metabolic syndromes, and this includes glucose- and lipid-lowering agents
• These criteria must be met, even in volunteers receiving glucose- or lipid-lowering agents, so that we enroll participants who have developed metabolic syndromes that are not normalized by traditional pharmacologic approaches
• Volunteers receiving glucose- or lipid-lowering agents who have normalized their lipid, glucose and insulin levels below these defined limits, are not eligible to enroll.
• years old.
• Plasma HIV RNA \<15,000 copies/ml for previous 3months.
• CD4 count \>200 c/µL for previous 3 months.

You may not qualify if:

• Chronic hepatitis B infection (HB surface antigen positive). Active hepatitis C infection (detectable Hep C RNA). Those who have cleared hepatitis B or C infection are eligible.
• Diabetes \[fasting glucose \>140 mg/dL, or fasting insulin \>45 µU/mL, or 2-hr glucose \>200mg/dL\].
• History of diabetes mellitus that pre-dates HIV-infection. Medications or agents that regulate glucose or lipid metabolism (e.g., insulin-sensitizers, insulin-secretagogues, HMG-CoA reductase inhibitors ('statins'), fibrates, niacin) are permitted. A large percentage of ACTU subjects and ID Clinic patients receiving RTV-boosted regimens are also receiving lipid-lowering agents. Excluding them might significantly reduce the pool of potential enrollees. The glucose- or lipid-lowering agent and dose must be stable for at least 3 months prior to screening. Additionally, volunteers taking glucose-or lipid-lowering agents must still have dyslipidemia and impaired glucose tolerance criteria (above). If they are taking these agents and have 'normalized' their lipids/lipoproteins and hyperinsulinemia, then they are not eligible
• Gestational diabetes, pregnancy, or nursing mothers. Menstruating women must have a negative urine pregnancy test within 14 days prior to DEXA testing (minor radiation exposure from DEXA). To control for potential metabolic effects of alterations in female hormones during the menstrual cycle, all menstruating women will be tested during the follicular phase.
• Hypogonadism \[total testosterone \<200ng/dL (men) or \<15ng/dL (women)\]; thyroid disorder \[TSH \<0.2 or \>12µIU/mL\]; hypercortisolemia \[morning cortisol \>22µg/dL\]. Replacement testosterone or thyroid hormones or human growth hormone to normalize abnormal levels is acceptable, as long as treatment has been stable, and blood testosterone, TSH or IGF-1 levels are within the normal range.
• Unwilling or unable to attend supervised yoga sessions 3days/wk provided by Brentwood Center for Health at the Connectcare Clinic. Any condition that might be contraindicated for yoga therapy (disabling neuromuscular or musculoskeletal injury/disorder)
• Anticipated change in anti-HIV medications or other medications that affect metabolism, within the next 4months
• Well-trained athletes (defined as \>3 exercise training exposures/week; \>30min regimented exercise/exposure maintained for at least the prior 4 weeks)
• Active substance abuse (eg, alcoholism, cocaine, heroin, crack, methamphetamine, phencyclidine)
• Active secondary infection or a significant change in chronic suppressive therapy for an opportunistic infection during 1 month prior to enrollment
• New serious systemic infection during the 3 weeks prior to enrollment
• Recent episode of hyperlactatemia or lactic acidosis, esp. with rapid weight loss
• Chronic renal insufficiency/failure or other comorbid conditions (eg. cancer, COPD) that alter metabolism
• Pancreatitis, celiac disease, or cirrhosis
• Inadequate macronutrient or energy intake, or malabsorptive disorder as determined by the research dietician

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• 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.

  PMID: 18227915 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.

  PMID: 18566316 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.

  PMID: 18453813 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.

  PMID: 18453805 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.

  PMID: 18427203 BACKGROUND

• 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.

  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.

  PMID: 20059570 RESULT

MeSH Terms

Conditions

HIV Infections; Hypertension; Acquired Immunodeficiency Syndrome; Insulin Resistance; Diabetes Mellitus; Dyslipidemias; Cardiovascular Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Slow Virus Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kevin E Yarasheski, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 3, 2008
• Study Start: November 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 26, 2010

Record last verified: 2010-07

Locations

US (1)