Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Phase 1

• Conditions: Diabetic Cardiomyopathy
• Interventions: Drug: Perhexiline

• Registration Number: NCT00628056
• Lead Sponsor: University Hospital Birmingham

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Status Verified: 2008-02
• Study First Submitted: 2008-02-24
• Study First Submitted QC: 2008-02-24
• Last Update Submitted: 2008-02-24
• Study First Posted: 2008-03-04
• Last Update Posted: 2008-03-04
• Primary Completion: 2009-04
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Perhexiline	-
2	Perhexiline	-

Primary Outcome Measures

Name	Time	Method
The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.	2 Weeks

Trial Locations

Locations (1)

University of Birmingham; 🇬🇧 Birmingham, Westmidlands, United Kingdom