Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Diabetic Cardiomyopathy Clinical Trial

— DDCM  

Official title:

Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00628056
• Other study ID #: RRK3159
• Secondary ID: PG/06/104/21466
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 24, 2008
• Last updated: February 24, 2008
• Start date: October 2006
• Est. completion date: April 2009

Study information

• Verified date: February 2008
• Source: University Hospital Birmingham
• Contact: Ganesh Nallur Shivu, MBBS MRCP
• Phone: 0044 1214145916
• Email: drgani23[@]gmail.com
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetic Cardiomyopathies
• Diabetic Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	Westmidlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Birmingham	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.		2 Weeks	No