Status:
UNKNOWN
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Lead Sponsor:
University Hospital Birmingham
Collaborating Sponsors:
British Heart Foundation
Conditions:
Diabetic Cardiomyopathy
Eligibility:
All Genders
16-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. W...
Eligibility Criteria
Inclusion
- Diabetes Mellitus(WHO definition)
- HbA1C \<9
- No history of chest pain
- No evidence of Coronary Artery Disease or peripheral vascular disease
- Left ventricular ejection fraction over 50%
- No evidence of respiratory disease
Exclusion
- Patients \< 16years or who cannot provide informed consent
- Evidence of significant epicardial coronary artery disease
- Evidence of peripheral vascular disease
- Abnormal liver function tests
- Clinically apparent peripheral neuropathy
- Severe chronic renal failure (creatinine \>250) or diabetic nephropathy
- Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
- Patients on statin therapy for primary dyslipidemia.
- Patients with recurrent hypoglycaemia
- Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00628056
Start Date
October 1 2006
End Date
April 1 2009
Last Update
March 4 2008
Active Locations (1)
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1
University of Birmingham
Birmingham, Westmidlands, United Kingdom, B15 2TT