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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

February 24, 2008
February 24, 2008
October 2006
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Diabetic Cardiomyopathy
Drug: Perhexiline
Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
  • Active Comparator: 1
    Intervention: Drug: Perhexiline
  • Placebo Comparator: 2
    Intervention: Drug: Perhexiline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
April 2009
April 2009   (final data collection date for primary outcome measure)

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)
Both
16 Years to 80 Years
No
Contact: Ganesh Nallur Shivu, MBBS MRCP 0044 1214145916 drgani23@gmail.com
United Kingdom
 
NCT00628056
RRK3159, PG/06/104/21466
No
Prof Michael Frenneaux, University of Birmingham
University Hospital Birmingham
British Heart Foundation
Principal Investigator: Michael Frenneaux, MD FRCP FACC University of Birmingham
University Hospital Birmingham
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP