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

This study is currently recruiting participants.

Verified by University Hospital Inselspital, Berne, April 2006

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00325559

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 1 Exercise	Procedure: Normoinsulinemic eu- or hyperglycemic clamp

MedlinePlus related topics: Diabetes Diabetes Type 1 Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
IMCL content during exercise in the working muscle
Rate of appearance of glucose
Rate of disappearance of glucose
Rate of glucose infusion
Total glucose oxidation
Oxidation of endogenous glucose
Oxidation of exogenous glucose
Fat oxidation (calculated via tracer and via RER)
Rate of perceived exertion
Serum lactate levels during the exercise test
Amino acid oxidation
Serum free fatty acid concentration
Serum insulin levels
Serum glucose levels
Time to achieve hyperglycemia during clamp
Pretest diary data

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Male

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325559

Contacts

Contact: Stefan Jenni

+41 (31) 632 40 70

stefan.jenni@insel.ch

Locations

Switzerland
Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital	Recruiting
Bern, Switzerland, CH-3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Christoph Stettler, MD

University Hospital of Bern

More Information

Publications indexed to this study:

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. Epub 2008 May 30.

Study ID Numbers:	1122
Study First Received:	May 12, 2006
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00325559
Health Authority:	Switzerland: Ethikkommission

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009