Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes (DDCM)

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Diabetic Cardiomyopathy

Treatments

Drug: Perhexiline

Study type

Interventional

Funder types

Other

Identifiers

NCT00628056

RRK3159

PG/06/104/21466

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

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)