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Metabolic Syndrome XPhase 3NCT00147264

Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial

A Phase 3 study of Metabolic Syndrome X, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Metabolic Syndrome X
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteCanada
Study dates
Apr 2004to Nov 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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.
  • contraindications to study diet
  • any major surgery that is, at the time of screening, planned to take place during the study period.
  • previously angioedema with ACE Inhibitor or ARB or known hypersensitivity to any component of the study drug formulations (e.g. hereditary fructose intolerance)
  • history of drug or alcohol dependency within six months prior to signing the informed consent form.
  • history of active malignancy, chronic inflammatory disorder, or chronic infections which would interfere with protocol completion.
  • any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol and/or safe administration of trial medication
  • If the participant has any contraindications to MRI
  • Pre-menopausal women (last menstruation >=1 year prior to consent) who:
  • are not surgically sterile or
  • are nursing, or pregnant, or
  • are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study, AND do not agree to periodic pregnancy testing during participation in the study.
  • Intention to go on weight - reducing medications or weight-loss diets during the study period
  • Significant fluctuations in weight over past 3 months(e.g. >10%)
  • Household member currently in study
  • Any investigational drug therapy within one month of signing the informed consent form.
  • Participant has knowledge that he/she will be unable to consume study foods for >2 weeks during treatment phase of study
  • <70% compliant during run-in
  • Unable to reduce total fat consumption to <40% and/or reduce saturated fat consumption to <15% during run-in

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: A Randomized, Double Blind, 2X2 Factorial Design Study to Evaluate the Effects of Telmisartan vs Placebo, and of a Low-Glycemic Diet vs Control Diet, in Reducing Intra-Myocellular Lipids In Individuals With Abdominal Obesity

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.

Read the detailed description

The metabolic syndrome currently affects over 20% of the adult population in Canada. Patients with abdominal obesity are at markedly increased risk for diabetes and heart disease. Recent studies have shown that decreased sensitivity to insulin (insulin resistance), a hallmark of the metabolic syndrome, is related to increased storage of fat in muscle cells (muscle fat). Several recent studies indicate that blocking the renin-angiotensin system (RAS) may improve insulin sensitivity and prevent the development of type 2 diabetes. Other data suggests that this effect may be due to the effect of RAS blockade on the recruitment and growth of adipose tissue. The primary aim of this study is therefore to explore the role of angiotensin II in the development of insulin resistance. Specifically, we will examine the mechanisms underlying the putative anti-diabetic effect of RAS blockade by examining the effect of angiotensin receptor blockade on muscle fat content in individuals with the abdominal obesity. This study will therefore test the hypothesis that treatment with the angiotensin receptor blocker telmisartan (Micardis®) will reduce muscle fat, thereby improving insulin sensitivity in people with abdominal obesity, with or without additional features of the metabolic syndrome. A number of dietary factors can also affect insulin sensitivity and may influence muscle fat. Recent studies suggest that increasing the content of low-glycemic foods (carbohydrates which are less easily digested), can improve insulin sensitivity and lipid profile in patients with insulin resistance. A second aim of this study is therefore to test the hypothesis that a low-glycemic diet will reduce muscle fat, thereby improving insulin sensitivity in this population.

Being tested
Telmisartan (Micardis®) vs. Placebo, Low-Glycemic Index Diet vs. Control Diet
Keywords
insulin resistance, myocellular lipids, adipose tissue
Medical subject headings
Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telmisartan (Micardis®) vs. PlaceboDrug

  • Low-Glycemic Index Diet vs. Control DietBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

  2. Change in insulin sensitivity as determined by HOMA index

  3. Reversal of IFG to normal fasting glucose in participants with IFG

  4. Change in 72-hour subcutaneous glucose profile

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

  6. Change in serum/plasma levels of inflammatory markers (C-reactive protein, adiponectin, tumor necrosis factor a, interleukin 6, leptin, adhesion molecules, plasminogen-activation inhibitor-1, t-PA, global test of fibrinolysis, fibrinogen, homocysteine,

  7. Change in beta-cell function as assessed by the Insulin Secretion Index

  8. Other efficacy parameters of the AT1 blockade and LGI diet are:

  9. Change in waist circumference

  10. Change in body composition as assessed by bioelectrical impedance analysis

  11. Change in abdominal (visceral) adipose tissue as assessed by MRI

  12. Change in resting blood pressure

  13. Change in adipocytic cell size determined by grouped diameter distribution in subcutaneous abdominal adipose tissue biopsies

  14. Changes in mRNA expression of genes in adipose tissue for genes involved in adipose tissue differentiation, growth, metabolism, cardiovascular function and inflammation.

  15. Change in muscle triglyceride content (histochemical examination of muscle biopsies)

  16. Change in molecular markers of endoplasmic reticular stress in circulating blood cells

  17. Endothelial function as assessed by Doppler ultrasound of the forearm blood flow.

  18. Systolic and diastolic cardiac function as assessed by echocardiography

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionJan 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147264
Sponsor's protocol ID
502.433
Other IDs
BI Pharmaceuticals - 502.433, CIHR - 116099
Status last verified
Dec 2016
First submitted
2 Sep 2005
Last updated
14 Dec 2016
Results posted
No

Publications

  • 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.

    PubMed 23731019

  • 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.

    PubMed 22090469

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Metabolic Syndrome X, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(for both interventions): change in IMCL content in the soleus muscle as assessed by 1H-MRI Spectroscopy at baseline and 6 months. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147264, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.

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