Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Collaborator: British Heart Foundation
• Treatments: Perhexiline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)