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Diabetes Mellitus, Type 2Phase 4NCT00424762

Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride

A Phase 4 study testing rosiglitazone in people with Diabetes Mellitus, Type 2, run by University of Texas Southwestern Medical Center at 1 site in United States.

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 if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic) triglyceride (TG) deposition in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
rosiglitazone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteUnited States
Study dates
Feb 2005to Apr 2007
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • type 2 diabetes mellitus (prior clinical diagnosis and current use of hypoglycemic medical therapy or by new diagnosis according to ADA criteria) with at least one of the following:
  • prior diagnosis of cardiovascular disease (CAD, MI, revascularization, CVA/TIA, carotid or peripheral arterial disease)
  • at least one additional CVD risk factor (smoking, hypertension, hypercholesterolemia, albuminuria, family history of premature CAD, or documented hsCRP>3)

Who cannot join

  • treatment with a TZD within prior 6 months
  • documented intolerance to TZD
  • history or evidence of CHF
  • AST/ALT>3X upper limits of normal
  • creatinine >2.5

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9034

Other trials in United States

About this study

The purpose of this study is to determine if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic) triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR) techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac structure and function.

Read the detailed description

Cardiovascular disease (CVD), including congestive heart failure (CHF), accounts for over 75% of deaths among patients with diabetes. Thus, it is imperative to rigorously evaluate existing and emerging hypoglycemic therapies with regard to their cardiovascular consequences. The thiazolidinedione (TZD) class of drugs, alone or in combination with other oral hypoglycemic medications or with insulin, has emerged as a safe and effective treatment of hyperglycemia in type 2 diabetes. Both in vitro and in vivo studies have revealed favorable pleiotropic effects of TZD on myocyte and ventricular structure and function. However, approximately 10% of patients taking TZDs develop peripheral edema and some patients have developed heart failure decompensation on the drug. These observations have led to a Food and Drug Administration (FDA) warning regarding the use of TZDs in patients with or at high risk of developing congestive heart failure (CHF). The exact effects of TZDs on integrated cardiovascular performance remain unclear. The primary hypothesis of this study is that TZD treatment improves integrated cardiovascular performance in patients at risk for CHF by improving both central (i.e. cardiac output) and peripheral (i.e. vascular resistance) function.

Recently, we have developed a sensitive, reproducible noninvasive assay to measure intra-cardiomyocyte fat, which varies widely in amount between individuals. The relationship between the amount of cardiomyocyte triglyceride accumulation and LV mass and function remains unclear. TZDs have been previously shown to be associated with decreases in the TG content of the liver and muscle. The secondary hypothesis being tested in this study is that TZD treatment improves cardiac function by decreasing intra-cardiac myocyte triglyceride content.

Comparisons:

  • Peak oxygen uptake (VO2) during cardiopulmonary exercise testing in individuals randomized to rosiglitazone, compared to those on placebo.
  • Amount of intra-myocardial triglycerides using NMR techniques in in individuals randomized to rosiglitazone, compared to those on placebo.
Being tested
rosiglitazone, placebo
Keywords
Diabetes Mellitus, Type 2, Congestive Heart Failure, Cardiopulmonary exercise testing, intracellular cardiomyocyte triglycerides, thiazolidinedione, rosiglitazone, nuclear magnetic resonance
Medical subject headings
Diabetes Mellitus, Type 2, Heart Failure

What participants receive

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

  • rosiglitazoneDrug

    Also called Avandia

    6 months of treatment of blinded study drug

  • placeboDrug

    blinded treatment with matching placebo

Study groups in NCT00424762
Study groupRoleWhat they receive
rosiglitazoneExperimental4mg titrated to 8mg daily
Receives: Drug: rosiglitazone
PlaceboPlacebo comparatorblinded matching placebo treatment
Receives: Drug: placebo

What is being measured

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

  1. Peak Oxygen Uptake (VO2)

    measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute

    Measured: 6 months

Secondary outcomes (2)

  1. Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months

    proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)

    Measured: 6 months

  2. Percentage of Patients Developing New or Worsening Peripheral Edema

    clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline

    Measured: 6 months

Timeline

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

  1. First posted22 Jan 2007 (estimated)
  2. Study startFeb 2005
  3. Primary completionApr 2007
  4. Study completionApr 2007

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424762
Sponsor's protocol ID
GSK 102610
Status last verified
Apr 2012
First submitted
18 Jan 2007
Last updated
4 Apr 2012
Data monitoring committee
No

Publications

  • McGuire DK, See R, Abdullah SM, Snell PG, McGavock JM, Ayers CR, Szczepaniak LS. The effect of rosiglitazone on integrated cardiovascular performance, cardiac structure, function and myocardial triglyceride: trial design and rationale. Diab Vasc Dis Res. 2009 Jan;6(1):43-50. doi: 10.3132/dvdr.2009.009.

    PubMed 19156629

  • McGuire DK, Abdullah SM, See R, Snell PG, McGavock J, Szczepaniak LS, Ayers CR, Drazner MH, Khera A, de Lemos JA. Randomized comparison of the effects of rosiglitazone vs. placebo on peak integrated cardiovascular performance, cardiac structure, and function. Eur Heart J. 2010 Sep;31(18):2262-70. doi: 10.1093/eurheartj/ehq228. Epub 2010 Jul 2.

    PubMed 20601395

  • Jarvie JL, Pandey A, Ayers CR, McGavock JM, Senechal M, Berry JD, Patel KV, McGuire DK. Aerobic Fitness and Adherence to Guideline-Recommended Minimum Physical Activity Among Ambulatory Patients With Type 2 Diabetes Mellitus. Diabetes Care. 2019 Jul;42(7):1333-1339. doi: 10.2337/dc18-2634. Epub 2019 May 21.

    PubMed 31221698

  • McGavock J, Szczepaniak LS, Ayers CR, Abdullah SM, See R, Gore MO, Drazner MH, de Lemos JA, McGuire DK. The effects of rosiglitazone on myocardial triglyceride content in patients with type 2 diabetes: a randomised, placebo-controlled trial. Diab Vasc Dis Res. 2012 Apr;9(2):131-7. doi: 10.1177/1479164111428628. Epub 2011 Nov 8.

    PubMed 22067724

  • Narang N, Armstead SI, Stream A, Abdullah SM, See R, Snell PG, McGavock J, Ayers CR, Gore MO, Khera A, de Lemos JA, McGuire DK. Assessment of cardiac structure and function in patients without and with peripheral oedema during rosiglitazone treatment. Diab Vasc Dis Res. 2011 Apr;8(2):101-8. doi: 10.1177/1479164111403334.

    PubMed 21562061

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone in people with Diabetes Mellitus, Type 2, run by University of Texas Southwestern Medical Center at 1 site in United States.

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 3 inclusion and 5 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 4 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peak Oxygen Uptake (VO2) (time frame: 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 NCT00424762, which also lists 5 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 4 Apr 2012.

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