- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00325559
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
Status
Completed
Conditions
Intervention / Treatment
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
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Bern, Switzerland, CH-3010
- Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital
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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 |
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Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
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Secondary Outcome Measures
Outcome Measure |
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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
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IMCL content during exercise in the working muscle
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Rate of appearance of glucose
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Rate of disappearance of glucose
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Rate of glucose infusion
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Total glucose oxidation
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Oxidation of endogenous glucose
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Oxidation of exogenous glucose
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Fat oxidation (calculated via tracer and via RER)
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Rate of perceived exertion
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Serum lactate levels during the exercise test
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Amino acid oxidation
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Serum free fatty acid concentration
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Serum insulin levels
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Serum glucose levels
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Time to achieve hyperglycemia during clamp
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Pretest diary data
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1122 (Jian-jun Li)
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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