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 range
28 Years – 50 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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.