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

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ClinicalTrials.gov Identifier: NCT00628056
Recruitment Status : Unknown
Verified February 2008 by University Hospital Birmingham.
Recruitment status was:  Recruiting
First Posted : March 4, 2008
Last Update Posted : March 4, 2008
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospital Birmingham

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.

Condition or disease Intervention/treatment Phase
Diabetic Cardiomyopathy Drug: Perhexiline Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Study Start Date : October 2006
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Perhexiline
Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
Placebo Comparator: 2 Drug: Perhexiline
Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks



Primary Outcome Measures :
  1. The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio. [ Time Frame: 2 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628056


Contacts
Contact: Ganesh Nallur Shivu, MBBS MRCP 0044 1214145916 drgani23@gmail.com

Locations
United Kingdom
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

Responsible Party: Prof Michael Frenneaux, University of Birmingham
ClinicalTrials.gov Identifier: NCT00628056     History of Changes
Other Study ID Numbers: RRK3159
PG/06/104/21466
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: February 2008

Keywords provided by University Hospital Birmingham:
Perhexiline
diabetes
diabetic cardiomyopathy
high energy phosphate kinetics
magnetic resonance spectroscopy

Additional relevant MeSH terms:
Cardiomyopathies
Diabetic Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Perhexiline
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents