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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

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 15, 2006
Last Update Posted Date January 13, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Official Title  ICMJE The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Exercise
Intervention  ICMJE Procedure: Normoinsulinemic eu- or hyperglycemic clamp
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 12, 2006)
10
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325559
Other Study ID Numbers  ICMJE 1122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Stettler, MD University Hospital of Bern
PRS Account University Hospital Inselspital, Berne
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP