AzTrials
AzTrials

HIV InfectionsPhase 4NCT00627380

Yoga for the Management of HIV-Metabolic Syndromes

A Phase 4 study testing Yoga lifestyle intervention in people with HIV Infections and HIV Metabolic Cardiovascular Syndrome, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Yoga lifestyle intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 23Show fewer
  • 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.
  • 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:
  • platelet count >30,000/mm3
  • absolute neutrophil count >750/mm3
  • transaminases <5x the upper limit of normal
  • creatinine <3x the upper limit of normal
  • albumin >30g/L

Who cannot join

  • 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)
Show all 19Show fewer
  • History of serious cardiovascular disease; MI, unstable angina, heart failure, congenital heart disease, coronary artery disease, resting ST-segment depression >1mm, coronary artery bypass graft, stroke, sinus tachycardia, arrhythmias, premature atrial or ventricular contractions, claudication. Bundle branch block is exclusionary because it limits the interpretability of the resting/exercise ECG. Cardiovascular contraindications to maximal exercise testing
  • 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
  • Dementia or any condition that would prevent voluntary informed consent or compliance
  • Other compounds or blinded investigational new drugs that might affect metabolism or confound data interpretation (eg. RU486, interleukin therapy, or cytokine-receptor antagonist)
  • Oral glucocorticoid or corticosteroid use within the previous 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the detailed description

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:

  1. The safety of practicing a yoga lifestyle in HIV-infected people treated with HAART who are experiencing metabolic and anthropometric syndromes.
  2. To quantify the effects of practicing a yoga lifestyle on metabolic and anthropomorphic syndromes in HIV-infected people treated with HAART who are experiencing these syndromes.
  3. To quantify the effects of practicing a yoga lifestyle on cardiovascular disease (CVD) risk in HIV-infected people treated with HAART who are at increased CVD risk because of existing metabolic and anthropomorphic syndromes.
Being tested
Yoga lifestyle intervention, Standard of care
Keywords
HIV, AIDS, insulin resistance, diabetes, dyslipidemia, visceral adiposity, subcutaneous adipose wasting, cardiovascular disease, hypertension, endothelial function, quality of life, Complementary Therapies
Medical subject headings
HIV Infections, Hypertension, Acquired Immunodeficiency Syndrome, Insulin Resistance, Diabetes Mellitus, Dyslipidemias, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga lifestyle interventionBehavioural

    Also called Hatha yoga, Ashtanga yoga

    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.

  • Standard of careOther

    Also called Observation control group

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

Study groups in NCT00627380
Study groupRoleWhat they receive
STOCPlacebo comparatorStandard 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
Receives: Other: Standard of care
YOGAExperimentalYoga lifestyle intervention administered by certified yoga instructor.
Receives: Behavioral: Yoga lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy outcome is a metabolic parameter: insulin integrated area under the curve (AUC) during the oral glucose tolerance test.

    Measured: Baseline and week 16

Secondary outcomes (5)

  1. Fasting lipid/lipoprotein levels.

    Measured: Baseline and week 16

  2. Body composition: visceral and subcutaneous adipose tissue areas (VAT, SAT), trunk/limb adipose ratio.

    Measured: Baseline and week 16

  3. Cardiovascular disease risk: Framingham 10-yr CVD risk calculation

    Measured: Baseline and week 16

  4. Quality of life: SF36 MOS

    Measured: Baseline and week 16

  5. Safety: CD4 count and plasma HIV RNA

    Measured: Baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2008 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00627380
Sponsor's protocol ID
R21AT003083
Other IDs
R21AT003083, WU187
Status last verified
Jul 2010
First submitted
28 Feb 2008
Last updated
26 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18227915

  • 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.

    PubMed 18566316

  • 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.

    PubMed 18453813

  • 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.

    PubMed 18453805

  • 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.

    PubMed 18427203

  • 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.

  • 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.

    PubMed 20059570

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Yoga lifestyle intervention in people with HIV Infections and HIV Metabolic Cardiovascular Syndrome, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy outcome is a metabolic parameter: insulin integrated area under the curve (AUC) during the oral glucose tolerance test. (time frame: Baseline and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00627380, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in