Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473876
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2007-05-15
Brief Title:
Metformin in Insulin Resistant Left Ventricular LV Dysfunction TAYSIDE Trial
Sponsor:
University of Dundee
Organization:
University of Dundee
Study Overview
Official Title:
Metformin in Insulin Resistant LV Dysfunction a Double-blind Placebo-controlled Trial TAYSIDE Trial
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAYSIDE
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None