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

January 12, 2011 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christoph Stettler, MD, University Hospital of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

January 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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