Back to results

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

Primary Purpose

Diabetic Cardiomyopathy

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Perhexiline

About this trial

This is an interventional basic science trial for Diabetic Cardiomyopathy focused on measuring Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.

Secondary Outcome Measures

Full Information

NCT ID

NCT00628056

First Posted

February 24, 2008

Last Updated

February 24, 2008

Sponsor

University Hospital Birmingham

Collaborators

British Heart Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00628056

Brief Title

Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Acronym

DDCM

Official Title

Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

April 2009 (Anticipated)

Study Completion Date

April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Birmingham

Collaborators

British Heart Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Cardiomyopathy

Keywords

Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Perhexiline

Intervention Description

Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks

Primary Outcome Measure Information:

Title

The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.

Time Frame

2 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ganesh Nallur Shivu, MBBS MRCP

Phone

0044 1214145916

drgani23@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Frenneaux, MD FRCP FACC

Organizational Affiliation

University of Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Birmingham

City

Birmingham

State/Province

Westmidlands

ZIP/Postal Code

B15 2TT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Frenneaux, MD FRCP FACC

12. IPD Sharing Statement

Learn more about this trial

Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

We'll reach out to this number within 24 hrs