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

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ClinicalTrials.gov Identifier: NCT00325559
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Exercise Procedure: Normoinsulinemic eu- or hyperglycemic clamp Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Official Title: The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Study Start Date : June 2006
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia

Secondary Outcome Measures :
  1. 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
  2. IMCL content during exercise in the working muscle
  3. Rate of appearance of glucose
  4. Rate of disappearance of glucose
  5. Rate of glucose infusion
  6. Total glucose oxidation
  7. Oxidation of endogenous glucose
  8. Oxidation of exogenous glucose
  9. Fat oxidation (calculated via tracer and via RER)
  10. Rate of perceived exertion
  11. Serum lactate levels during the exercise test
  12. Amino acid oxidation
  13. Serum free fatty acid concentration
  14. Serum insulin levels
  15. Serum glucose levels
  16. Time to achieve hyperglycemia during clamp
  17. Pretest diary data


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325559     History of Changes
Other Study ID Numbers: 1122
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: January 13, 2011
Last Verified: January 2011

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