Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome

Completed · Not applicable

Conditions studied: HIV Infections, Cardiovascular Disease, Insulin Resistance, HIV Lipodystrophy, The Metabolic Syndrome

In brief

We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize fats and sugars inappropriately, and that this may impair the heart's ability to pump blood. We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of exercise training and pioglitazone for improving insulin resistance, heart metabolism and heart function in this at risk population.

Key facts

Study ID

NCT00656851

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

24

Starts

2005-09-01

Expected to finish

2010-08-01

Last updated by the study team

2013-08-28

Who can join

Age: 28 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Frank obesity (BMI >35kg/m2).
• 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 >125 mg/dL, or fasting insulin >45 µU/mL, or 2-hr glucose >200mg/dL].
• Medications or agents that regulate glucose metabolism (e.g., insulin-sensitizers, insulin-secretagogues). Lipid lowering agents that regulate lipid metabolism (i.e. fibrate, statin).
• Gestational diabetes, pregnancy, or nursing mothers.
• Serum triglycerides ≥ 500 mg/dL.
• 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 to normalize abnormal levels is acceptable, as long as treatment and blood levels have been stable for at least 3 months.
• Use of human growth hormone (hGH) or GH-secretagogues (GH-releasing hormone-peptides) within the previous 3 months.
• History of serious cardiovascular disease; MI, angina pectoris, heart failure, congenital heart disease, coronary artery disease, coronary artery bypass graft, stroke. Bundle branch block is exclusionary because it limits the interpretability of the resting/exercise ECG. Cardiovascular or physical contraindications to maximal exercise testing on a cycle ergometer.
• Uncontrolled hypertension (>140/90 mmHg). Certain antihypertensive medications will be permitted (diuretics, ACE inhibitors) as long as the medication, dose, and blood pressure have been stable for at least 3 months.
• Well-trained athletes (defined as >3 exercise training exposures/week; >30min regimented exercise/exposure maintained for at least the prior 4 weeks).
• History of or active substance abuse (eg, alcoholism, cocaine, heroin, crack, methamphetamine, phencyclidine).
• Active secondary infection. Any 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.
• History of hyperlactatemia or lactic acidosis, esp. with rapid weight loss.
• Debilitating-painful myopathy or neuropathy that requires 'assistance' to conduct normal activities of daily living (dressing, hygiene, preparing meals, operating a vehicle). These might affect peripheral substrate metabolism.
• 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.
• 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 previous 3 months.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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