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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00628056
First received: February 24, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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
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

  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
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

No publications provided

Responsible Party: Prof Michael Frenneaux, University of Birmingham
ClinicalTrials.gov Identifier: NCT00628056     History of Changes
Other Study ID Numbers: RRK3159, PG/06/104/21466
Study First Received: February 24, 2008
Last Updated: February 24, 2008
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

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

ClinicalTrials.gov processed this record on May 21, 2013