Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial)
Overview[ - collapse ][ - ]
| Purpose | Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)? |
|---|---|
| Condition | Congestive Heart Failure Insulin Resistance |
| Intervention | Drug: Metformin Drug: Matched Placebo (Capsules) |
| Phase | Phase 4 |
| Sponsor | University of Dundee |
| Responsible Party | University of Dundee |
| ClinicalTrials.gov Identifier | NCT00473876 |
| First Received | May 15, 2007 |
| Last Updated | May 28, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2007 |
|---|---|
| Last Updated Date | May 28, 2013 |
| Start Date | August 2007 |
| Estimated Primary Completion Date | April 2009 |
| Current Primary Outcome Measures | Peak VO2 [Time Frame: 4 months] [Designated as safety issue: No]Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo. |
| Current Secondary Outcome Measures | Possible Mechanisms That Can Explain the Improvement of Exercise Capacity [Time Frame: 4 months] [Designated as safety issue: No]VE/VCO2 Slope, measurement of the abnormal ventilatory response to exercise identified by an increased slope of ventilation (L/min) vs. CO2 production (VE/VCO2) (L/min) to incremental workload |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial) |
|---|---|
| Official Title | Metformin in Insulin Resistant LV Dysfunction, a Double-blind, Placebo-controlled Trial (TAYSIDE Trial) |
| Brief Summary | Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)? |
| Detailed Description | 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 1. The effect of metformin on the heart? We will answer this question by doing an ultrasound scan of the heart (Echocardiography) 2. The effects on the blood vessels? We plan to perform a test called flow-mediated dilatation, it is an ultrasound scan of the artery in the arm and also assess the blood flow in the skin using a test called Laser Doppler scan (small amount of medication will be delivered through a small electric current and the blood vessels response will be assessed using the laser doppler scan) 3. The effects on the muscle? We will do a muscle biopsy looking at the enzymes activities in the muscle before and after taking 4 months of medication. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Metformin Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks Drug: Matched Placebo (Capsules) Similar dosing regime as active comparator |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 62 |
| Estimated Completion Date | April 2009 |
| Estimated Primary Completion Date | April 2009 |
| Eligibility Criteria | Inclusion Criteria: - Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of insulin resistance [fasting insulin resistance index values of > 2.7 are said to have insulin resistance]. - Documented Left ventricular systolic dysfunction or LV ejection fraction < 35% Exclusion Criteria: - Elderly patients (aged >80 yrs); - Patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF); - Renal dysfunction (serum creatinine > 160 mmol/L); - Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance. Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded. - Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion; - Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease .i.e., uncontrolled hypertension: SBP>180 mmHg or DBP, recent stroke, any severe chronic disease (including renal and hepatic disease). |
| Gender | Both |
| Ages | 25 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00473876 |
|---|---|
| Other Study ID Numbers | WON001 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Dundee |
| Study Sponsor | University of Dundee |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Chim Lang, MD, FRCP University of Dundee, Scotland |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Medicine and Therapeutics, Ninewells Hospital | Dundee, Scotland, United Kingdom, DD1 9SY |
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