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Sponsored by: |
University of Dundee |
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Information provided by: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00473876 |
Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)?
Condition | Intervention | Phase |
---|---|---|
Congestive Heart Failure Insulin Resistance |
Drug: Metformin Drug: Matched Placebo (Capsules) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Metformin in Insulin Resistant LV Dysfunction, a Double-Blind, Placebo-Controlled Trial (TAYSIDE Trial) |
Estimated Enrollment: | 66 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Receiving Metformin for 4 months
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Drug: Metformin
Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks
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2: Placebo Comparator
Matched Placebo for 4 months
|
Drug: Matched Placebo (Capsules)
Similar dosing regime as active comparator
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Exercise incapacity is one of the major debilitating symptoms of heart failure patients. Studies showed that heart failure patients will become insulin resistance (IR) or vice versa, severity of heart failure also correlates with the severity of insulin resistance. A recent study demonstrated that if we correct diabetic patient insulin resistance by giving them a drug to make them more sensitive to the effects of insulin, their exercise capacity improves. Therefore, we think that the same effects might happen in heart failure patients who have been identified to the insulin resistance by blood test. Insulin resistance means that they have not yet become diabetic and it is a stage the diabetic patients go through before they develop diabetes.
Therefore, we plan to use a drug called metformin (a diabetic drug), give it to heart failure patients who also have IR for 4 months and examine the effects before and after 4 months of treatment. It is a double blind control study, therefore, neither the examiner nor the patient know which drug they receive (either active drug- Metformin, or a placebo).
The main objective is to assess their exercise capacity using an exercise test called Innocor System. It is a bicycle based exercise test that involves patient breathing into a mouth piece before and during exercise in order for the machine to work out the maximum oxygen consumption and pumping power of the heart.
The other objectives of the trial are looking at the possible mechanisms of improving exercise capacity. We aim to answer the following questions by doing the following tests:
Does exercise capacity improve because of
Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aaron K Wong, MBChB, MRCP | 0044(0)1382660111 ext 33176 | a.k.f.wong@dundee.ac.uk |
Contact: Chim C Lang, FRCP | 0044(0)1382660111 | c.c.lang@dundee.ac.uk |
United Kingdom, Scotland | |
Medicine and Therapeutics, Ninewells Hospital | Recruiting |
Dundee, Scotland, United Kingdom, DD1 9SY |
Principal Investigator: | Chim Lang, MD, FRCP | University of Dundee, Scotland |
Responsible Party: | University of Dundee ( Dr Aaron KF Wong ) |
Study ID Numbers: | WON001 |
Study First Received: | May 15, 2007 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00473876 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Chronic Heart Failure Insulin Resistance Metformin Peak VO2 |
Hyperinsulinism Heart Failure Metabolic Diseases Heart Diseases Metformin |
Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |