The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Exercise; Diabetes Mellitus, Type 1

• Registration Number: NCT00325559
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Study Start: 2006-06
• Primary Completion: 2007-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia

Secondary Outcome Measures

Name	Time	Method
Oxidation of endogenous glucose
Serum lactate levels during the exercise test
Amino acid oxidation
IMCL content during exercise in the working muscle
Total glucose oxidation
Muscle glycogen content during exercise in the working muscle (pre test vs. post test), in euglycaemia and hyperglycaemia respectively (All following endpoints are paired differences (euglycaemia vs. hyperglycaemia) of paired differences (pre
Rate of appearance of glucose
Rate of disappearance of glucose
Rate of glucose infusion
Fat oxidation (calculated via tracer and via RER)
Oxidation of exogenous glucose
Rate of perceived exertion
Serum insulin levels
Serum glucose levels
Pretest diary data
Time to achieve hyperglycemia during clamp
Serum free fatty acid concentration

Trial Locations

Locations (1)

Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital; 🇨🇭 Bern, Switzerland