Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes - Full Text View

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

This study is currently recruiting participants.

Verified by University Hospital Birmingham, February 2008

Sponsors and Collaborators:	University Hospital Birmingham British Heart Foundation
Information provided by:	University Hospital Birmingham
ClinicalTrials.gov Identifier:	NCT00628056

Purpose

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.

Condition	Intervention	Phase
Diabetic Cardiomyopathy	Drug: Perhexiline	Phase I Phase II

MedlinePlus related topics: Cardiomyopathy Diabetes

Drug Information available for: Perhexiline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment
Official Title:	Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:

The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio. [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Perhexiline Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
2: Placebo Comparator	Drug: Perhexiline Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628056

Contacts

Contact: Ganesh Nallur Shivu, MBBS MRCP

0044 1214145916

drgani23@gmail.com

Locations

United Kingdom, Westmidlands
University of Birmingham	Recruiting
Birmingham, Westmidlands, United Kingdom, B15 2TT
Principal Investigator: Michael Frenneaux, MD FRCP FACC

Sponsors and Collaborators

University Hospital Birmingham

British Heart Foundation

Investigators

Principal Investigator:

Michael Frenneaux, MD FRCP FACC

University of Birmingham

More Information

Responsible Party:	University of Birmingham ( Prof Michael Frenneaux )
Study ID Numbers:	RRK3159, PG/06/104/21466
Study First Received:	February 24, 2008
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00628056
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Birmingham:

Perhexiline
diabetes
diabetic cardiomyopathy
high energy phosphate kinetics
magnetic resonance spectroscopy

Study placed in the following topic categories:

Calcium, Dietary
Heart Diseases
Perhexiline
Diabetes Mellitus
Cardiomyopathies

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Calcium Channel Blockers
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009