Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome (NCT00656851) | Clinical Trial Compass
CompletedNot Applicable
Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome
United States24 participantsStarted 2005-09
Plain-language summary
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.
Who can participate
Age range28 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
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).
What they're measuring
1
Myocardial Glucose Utilization Rate
Timeframe: Weeks 0 and 16
2
Myocardial Glucose Utilization Rate Per Unit Insulin
Timeframe: Weeks 0 and 16
3
Myocardial Fatty Acid Utilization Rate
Timeframe: Weeks 0 and 16
4
Myocardial Fatty Acid Oxidation Rate
Timeframe: Weeks 0 and 16
5
Myocardial Fatty Acid Esterification
Timeframe: Weeks 0 and 16
Trial details
NCT IDNCT00656851
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
✕. 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.