Yoga for the Management of HIV-Metabolic Syndromes

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Brief Title

Yoga for the Management of HIV-Metabolic Syndromes

Official Title

Yoga for the Management of HIV-Metabolic Syndromes

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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Fasting lipid/lipoprotein levels.

Condition

HIV Infections

Intervention

Yoga lifestyle intervention

Study Arms / Comparison Groups

 STOC
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

60

Start Date

November 2005

Completion Date

June 2009

Primary Completion Date

June 2009

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        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

        Exclusion Criteria:

          -  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)

          -  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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Kevin E Yarasheski, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00627380

Organization ID

R21AT003083

Secondary IDs

R21AT003083


Study Sponsor

Washington University School of Medicine

Collaborators

 National Center for Complementary and Integrative Health (NCCIH)

Study Sponsor

Kevin E Yarasheski, PhD, Principal Investigator, Washington University School of Medicine


Verification Date

July 2010