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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00325559
First received: May 12, 2006
Last updated: January 12, 2011
Last verified: January 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


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: 10
Study Start Date: June 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Christoph Stettler, MD University Hospital of Bern
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325559     History of Changes
Other Study ID Numbers: 1122
Study First Received: May 12, 2006
Last Updated: January 12, 2011
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014