Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628056

Acronym

DDCM

Enrollment

Registered

2008-03-04

Start date

2006-10-31

Completion date

2009-04-30

Last updated

2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Cardiomyopathy

Keywords

Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy

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.

Interventions

DRUGPerhexiline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

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)

Design outcomes

Primary

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

Countries

United Kingdom

Contacts

Primary ContactGanesh Nallur Shivu, MBBS MRCP

drgani23@gmail.com0044 1214145916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026