Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

NCT ID: NCT00628056

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-04-30

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.

Conditions

Diabetic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Perhexiline

Intervention Type: DRUG

Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks

2

Group Type: PLACEBO_COMPARATOR

Perhexiline

Intervention Type: DRUG

Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks

Interventions

Perhexiline

Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

University Hospital Birmingham

OTHER

Sponsor Role: lead

Responsible Party

University of Birmingham

Principal Investigators

Michael Frenneaux, MD FRCP FACC

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

University of Birmingham

Birmingham, Westmidlands, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Ganesh Nallur Shivu, MBBS MRCP

Role: CONTACT

drgani23@gmail.com

0044 1214145916

Other Identifiers

PG/06/104/21466

Identifier Type: -

Identifier Source: secondary_id

RRK3159

Identifier Type: -

Identifier Source: org_study_id