Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

NCT00628056 | Unknown Phase 1

• 2 other identifiers: RRK3159PG/06/104/21466
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  2 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Perhexiline

2

PLACEBO COMPARATOR

Drug: Perhexiline

Interventions

Perhexiline DRUG

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

1; 2

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Birmingham: lead
• British Heart Foundation: collaborator

Study Sites (1)

University of Birmingham

Birmingham, Westmidlands, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetic Cardiomyopathies; Diabetes Mellitus

Interventions

Perhexiline

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Frenneaux, MD FRCP FACC

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ganesh Nallur Shivu, MBBS MRCP

CONTACT

0044 1214145916; drgani23@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 4, 2008
• Study Start: October 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 4, 2008

Record last verified: 2008-02

Locations

GB (1)