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Completed

NCT Number: NCT00325559

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital

Bern, CH-3010, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normoinsulinemic eu- or hyperglycemic clamp

Procedure

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
First posted
May 15, 2006
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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