Clinical trial NCT00325559: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Official title: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Exercise
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-05-15
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 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

Primary outcomes:
measure: Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
Secondary outcomes:
measure: 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
measure: IMCL content during exercise in the working muscle
measure: Rate of appearance of glucose
measure: Rate of disappearance of glucose
measure: Rate of glucose infusion
measure: Total glucose oxidation
measure: Oxidation of endogenous glucose
measure: Oxidation of exogenous glucose
measure: Fat oxidation (calculated via tracer and via RER)
measure: Rate of perceived exertion
measure: Serum lactate levels during the exercise test
measure: Amino acid oxidation
measure: Serum free fatty acid concentration
measure: Serum insulin levels
measure: Serum glucose levels
measure: Time to achieve hyperglycemia during clamp
measure: Pretest diary data
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital
Study officials:
affiliation: University hospital of Bern
name: Christoph Stettler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenni S, Oetliker C, Allemann S, Ith M, Tappy L, Wuerth S, Egger A, Boesch C, Schneiter P, Diem P, Christ E, Stettler C. Fuel metabolism during exercise in euglycaemia and hyperglycaemia in patients with type 1 diabetes mellitus--a prospective single-blinded randomised crossover trial. Diabetologia. 2008 Aug;51(8):1457-65. doi: 10.1007/s00125-008-1045-5. Epub 2008 May 30.