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

February 24, 2008 updated by: University Hospital Birmingham
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ganesh Nallur Shivu, MBBS MRCP
  • Phone Number: 0044 1214145916
  • Email: drgani23@gmail.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: Michael Frenneaux, MD FRCP FACC, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

February 24, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK3159
  • PG/06/104/21466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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