CompletedPhase 3

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 range30 Years – 70 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.

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.

What they're measuring

(for both interventions): change in IMCL content in the soleus muscle as assessed by 1H-MRI Spectroscopy at baseline and 6 months

Trial details

NCT IDNCT00147264

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-01

View on ClinicalTrials.gov More Metabolic Syndrome X trials