Mechanisms responsible for cardiac and skeletal muscle energetic impairment in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Registration Number: EUCTR2006-002638-39-GB

Lead Sponsor: niversity Hospitals of Birmingham NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Type I diabetes (WHO definition)
2.HbA1C <9,
3.No history of chest pain and no evidence of CAD or peripheral vascular disease
4.Left ventricular ejection fraction over 50%
5.No evidence of respiratory disease.

Group1 with diagnosis in the last 3 years and no evidence of microvascular disease.
Group 2 with 10-15 years since diagnosis (but age matched) and evidence of coronary microvascular dysfunction.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients:
1.Patients < 16years or who cannot provide informed consent
2.Evidence of significant epicardial coronary artery disease
3.Evidence of peripheral vascular disease
4.Abnormal liver function tests
5.Clinically apparent peripheral neuropathy (for Perhexiline intervention study)
6.Severe chronic renal failure (creatinine >250) or diabetic nephropathy
7.Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
8.Patients on statin therapy for primary dyslipidemia.
9.Patients with recurrent hypoglycaemia
10.Women of child bearing age who are not using effective contraception (or if pregnancy test positive)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary end point of the study will be the change in cardiac PCr/ATP ratio.;Secondary Objective: Secondary end points of the study will be changes in PCr recovery half time in skeletal muscle after exercise, mitochondrial coupling ratio in skeletal muscle, UCP expression in skeletal muscle and VO2max on exercise testing.;Primary end point(s): PCr/ATP ratio in the heart.

Secondary Outcome Measures