Status:
COMPLETED
The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Diabetes Mellitus, Type 1
Exercise
Eligibility:
MALE
20-40 years
Phase:
NA
Brief Summary
This study aims at investigating the effect of hyperglycaemia on physical performance and local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise conditions.
Eligibility Criteria
Inclusion
- Male
- Aged from 20 to 40 years
- Patients with type 1 diabetes mellitus lasting for at least 5 years (C-Peptide ≤ 0.3 nmol/l in the presence of a plasma glucose level ≥ 7 mmol/L, indicating insulin dependence)
- Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months
- Acceptable to good metabolic control, reflected by an HbA1c 5-8%
- Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight
- minimum 30' of moderate exercise 3 times per week
- BMI in the range of 18-25 kg/m2
Exclusion
- Chronic complications of diabetes:
- Microalbuminuria (Mogensen nephropathy stadium ≥ III)
- Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I)
- Proliferating retinopathy
- No history of macro-vascular complications
- Clinically relevant autonomous neuropathy
- Smoking
- Abnormal thyroid function
- Major depression, psychosis and other severe personality disorders, claustrophobia
- Active neoplasia
- Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.)
- Abnormal liver or renal function (creatinine \> 130 µmol/L; ASAT and ALAT \> 3 times the upper reference limit)
- Excessive alcohol consumption (\>60g/d) or drug-abuse
- Refusal to give written informed consent
- Participation in another study
- Patients, who are not suitable for the study according to the study physician
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00325559
Start Date
June 1 2006
Last Update
January 13 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital
Bern, Switzerland, CH-3010