Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial
Canada120 participantsStarted 2004-04
Plain-language summary
The purpose of this study is to determine whether telmisartan and/or a low-glycemic index diet are effective in reducing intra-myocellular lipid (muscle fat) content.
Who can participate
Age range
30 Years – 70 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.
Exclusion criteria
. diabetes mellitus and/or FBG \>=7.0 mmol/L on two separate occasions within the screening period
. uncontrolled hypertension (SBP \>=160 mmHg and/or DBP \>=100 mmHg) or known participants with secondary causes of hypertension
. biliary obstruction
. hepatic dysfunction as defined by SGPT (ALT) \> 3 times the upper limit of normal range
. renal dysfunction as defined by serum creatinine \> 130umol/L AND/OR proteinuria 1+ or greater (dipstick)
. serum triglycerides \>10 mmol/L
. history of hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
. sodium depletion or hyperkalemia.
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.
1This trial looked at whether telmisartan reduces fat stored inside muscle cells — called intra-myocellular lipids — in people with metabolic syndrome. Can you explain what role that type of fat plays in my condition, and whether that's something we should be tracking in my case?
2The trial measured changes using a specialized MRI technique called 1H-MRI Spectroscopy after 6 months of treatment. Is that kind of testing available or relevant for monitoring my metabolic syndrome, or are there more practical markers we'd use instead?
3Since this was a completed Phase 3 trial, there should be published results — have you seen the findings, and do they suggest telmisartan meaningfully improved metabolic syndrome in a way that might be relevant to my situation?
4Telmisartan is already an approved blood pressure medication, so if it also showed benefits for metabolic syndrome in this trial, would it make sense for me to discuss it as a treatment option with you, or are there other medications or lifestyle approaches you'd recommend trying first?
5Metabolic syndrome involves several overlapping risk factors like blood sugar, cholesterol, and blood pressure — can you help me understand whether a drug targeting muscle fat storage, like what this trial studied, would address my most pressing concerns, or whether a different approach would be a better fit for where I am right now?
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
(for both interventions): change in IMCL content in the soleus muscle as assessed by 1H-MRI Spectroscopy at baseline and 6 months