Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial

NCT00147264 | Completed Phase 3

• 3 other identifiers: 502.433BI Pharmaceuticals - 502.433CIHR - 116099
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome X

Keywords

insulin resistance, myocellular lipids, adipose tissue

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (18)

• Change in intra-hepatocellular lipid storage as assessed by 1H-MRI Spectroscopy

• Change in insulin sensitivity as determined by HOMA index

• Reversal of IFG to normal fasting glucose in participants with IFG

• Change in 72-hour subcutaneous glucose profile

• Change in fasting lipid profile (free fatty acids, triglyceride, total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol)

Interventions

Telmisartan (Micardis®) vs. Placebo DRUG

Low-Glycemic Index Diet vs. Control Diet BEHAVIORAL

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Between 30 and 70 years of age
• Abdominal obesity defined as increased waist circumference (Men \>102cm (\>40in), Women \>88cm (\>35in)), with or without any of the following additional criteria of the metabolic syndrome:
• Triglycerides \>=1.7mmol/L (\>=150 mg/dL and/or on prescribed lipid lowering medication for \> 3 months)
• HDL cholesterol
• Men \<1.0 mmol/L (\<40 mg/dL)
• Women \<1.3 mmol/L (\<50 mg/dL)
• Blood pressure \>=130 and/or \>=85 mmHg and/or on anti-hypertensive therapy (except ACE-I or ARB)
• Fasting glucose \>=6.1 mmol/L (\>=110 mg/dL)
• Ability and willingness to complete dietary and activity diaries and questionnaires.

You may not qualify if:

• Participant has taken ACE inhibitor or ARB in the last 3 months, or in the opinion of the study physician currently has indication for either of these medications
• Concurrent antidiabetic medication
• Use of systemic glucocorticosteroids (topical and inhaled are acceptable)
• On lipid-lowering medication and NOT on stable dose for the last three months
• If the participant has any one or more of the following medical disorders:
• 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.
• uncorrected volume depletion
• endocrine disorder (e.g. hyperthyroidism, Cushing's syndrome, acromegaly, etc.) Participants on thyroid-replacement therapy and TSH \< 5.0 mU/L may be enrolled in the study.

Sponsors & Collaborators

• McMaster University: lead
• Boehringer Ingelheim: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Heart and Stroke Foundation of Canada: collaborator
• Medtronic: collaborator

Study Sites (1)

Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

• Chetty VT, Damjanovic S, Gerstein H, Singh N, Yusuf S, Anand SS, Sharma AM. Metabolic effects of telmisartan in subjects with abdominal obesity: a prospective randomized controlled trial. Blood Press. 2014 Feb;23(1):54-60. doi: 10.3109/08037051.2013.791411. Epub 2013 Jun 3.

  PMID: 23731019 DERIVED

• Kochan AM, Wolever TM, Chetty VT, Anand SS, Gerstein HC, Sharma AM. Glycemic index predicts individual glucose responses after self-selected breakfasts in free-living, abdominally obese adults. J Nutr. 2012 Jan;142(1):27-32. doi: 10.3945/jn.111.146571. Epub 2011 Nov 16.

  PMID: 22090469 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Arya M Sharma, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: April 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

CA (1)