Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome (WU197)
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ClinicalTrials.gov Identifier: NCT00656851 |
Recruitment Status
:
Completed
First Posted
: April 11, 2008
Results First Posted
: August 20, 2013
Last Update Posted
: August 28, 2013
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections Cardiovascular Disease Insulin Resistance HIV Lipodystrophy The Metabolic Syndrome | Drug: Pioglitazone Behavioral: Exercise Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Myocardial Function, Free Fatty Acid and Glucose Metabolism in HIV Metabolic Syndrome |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Pioglitazone
Pioglitazone (Actos, 30mg/day for 16 weeks)
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Drug: Pioglitazone
30mg/day for 16 weeks
Other Name: Actos
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Active Comparator: Exercise Training
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
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Behavioral: Exercise Training
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Other Names:
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- Myocardial Glucose Utilization Rate [ Time Frame: Weeks 0 and 16 ]Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.
- Myocardial Glucose Utilization Rate Per Unit Insulin [ Time Frame: Weeks 0 and 16 ]Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.
- Myocardial Fatty Acid Utilization Rate [ Time Frame: Weeks 0 and 16 ]Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).
- Myocardial Fatty Acid Oxidation Rate [ Time Frame: Weeks 0 and 16 ]Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.
- Myocardial Fatty Acid Esterification [ Time Frame: Weeks 0 and 16 ]Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction
- Myocardial Contractile Function During Diastole [ Time Frame: Weeks 0 and 16 ]
Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:
- blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or "E" filling velocity.
- residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the "A" (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure.
- Myocardial Contractile Function During Systole [ Time Frame: Weeks 0 and 16 ]Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum
- Fasting Lipids and Lipoproteins [ Time Frame: Week 0 and 16 ]fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations
- Fasting Glucose Insulin and HOMA [ Time Frame: Week 0 and 16 ]fasting plasma glucose, insulin concentrations and HOMA-insulin resistance

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Ages Eligible for Study: | 28 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: All participants both with and without metabolic syndrome:
- 28-50 years old.
- Plasma HIV RNA less than 5,000 copies/mL for previous 3 months OR CD4 count greater than 100 cells/µL for previous 3 months.
- Stable for at least the past 3 months on any HAART regimen.
- "Normal" blood chemistries for at least 1 month prior to enrollment: platelet count >50,000/mm3, absolute neutrophil count >750/mm3, liver transaminases <2.5x the upper limit of normal (ULN), creatinine <1.3x ULN, albumin >30g/L, creatine kinase <5.9x ULN.
Menstruating women must have a negative urine beta-HCG pregnancy test within 14 days prior to study. To control for potential metabolic effects of alterations in female hormones during the menstrual cycle, all menstruating women will be studied during the follicular phase (serum 17beta-estradiol <165 pg/mL).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656851
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Kevin Yarasheski, PhD | Washington University School of Medicine |
Publications of Results:
Responsible Party: | Kevin Yarasheski, Professor of Medicine, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00656851 History of Changes |
Other Study ID Numbers: |
DK59531 (completed) HRPO 05-0976 |
First Posted: | April 11, 2008 Key Record Dates |
Results First Posted: | August 20, 2013 |
Last Update Posted: | August 28, 2013 |
Last Verified: | August 2013 |
Keywords provided by Kevin Yarasheski, Washington University School of Medicine:
HIV/AIDS Heart disease Diabetes Cardiovascular disease risk |
Dyslipidemia Visceral adiposity treatment experienced |
Additional relevant MeSH terms:
Syndrome HIV Infections Cardiovascular Diseases Metabolic Syndrome X Insulin Resistance Lipodystrophy Disease Pathologic Processes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |