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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00325559
• Date of registration: 12/05/2006
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
• Scientific title: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
• Date of first enrolment: June 2006
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00325559
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Christoph Stettler, MD
• Affiliation: University Hospital of Bern

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Exercise

Intervention(s)

Procedure: Normoinsulinemic eu- or hyperglycemic clamp

Primary Outcome(s)

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

Secondary Outcome(s)

Fat oxidation (calculated via tracer and via RER)

Rate of appearance of glucose

Rate of glucose infusion

Serum lactate levels during the exercise test

IMCL content during exercise in the working muscle

Serum insulin levels

Total glucose oxidation

Amino acid oxidation

Oxidation of exogenous glucose

Rate of perceived exertion

Oxidation of endogenous glucose

Pretest diary data

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

Serum free fatty acid concentration

Serum glucose levels

Time to achieve hyperglycemia during clamp

Rate of disappearance of glucose

Secondary ID(s)

1122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors