Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 9:12 PM
Study NCT ID:
NCT00325559
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2006-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-12', 'studyFirstSubmitDate': '2006-05-12', 'studyFirstSubmitQcDate': '2006-05-12', 'lastUpdatePostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia'}], 'secondaryOutcomes': [{'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'}, {'measure': 'IMCL content during exercise in the working muscle'}, {'measure': 'Rate of appearance of glucose'}, {'measure': 'Rate of disappearance of glucose'}, {'measure': 'Rate of glucose infusion'}, {'measure': 'Total glucose oxidation'}, {'measure': 'Oxidation of endogenous glucose'}, {'measure': 'Oxidation of exogenous glucose'}, {'measure': 'Fat oxidation (calculated via tracer and via RER)'}, {'measure': 'Rate of perceived exertion'}, {'measure': 'Serum lactate levels during the exercise test'}, {'measure': 'Amino acid oxidation'}, {'measure': 'Serum free fatty acid concentration'}, {'measure': 'Serum insulin levels'}, {'measure': 'Serum glucose levels'}, {'measure': 'Time to achieve hyperglycemia during clamp'}, {'measure': 'Pretest diary data'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '18512043', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male\n* Aged from 20 to 40 years\n* 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)\n* Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months\n* Acceptable to good metabolic control, reflected by an HbA1c 5-8%\n* Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight\n* minimum 30' of moderate exercise 3 times per week\n* BMI in the range of 18-25 kg/m2\n\nExclusion Criteria:\n\n* Chronic complications of diabetes:\n\n * Microalbuminuria (Mogensen nephropathy stadium ≥ III)\n * Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I)\n * Proliferating retinopathy\n * No history of macro-vascular complications\n * Clinically relevant autonomous neuropathy\n* Smoking\n* Abnormal thyroid function\n* Major depression, psychosis and other severe personality disorders, claustrophobia\n* Active neoplasia\n* Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.)\n* Abnormal liver or renal function (creatinine \\> 130 µmol/L; ASAT and ALAT \\> 3 times the upper reference limit)\n* Excessive alcohol consumption (\\>60g/d) or drug-abuse\n* Refusal to give written informed consent\n* Participation in another study\n* Patients, who are not suitable for the study according to the study physician"}, 'identificationModule': {'nctId': 'NCT00325559', 'briefTitle': 'The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1122'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Normoinsulinemic eu- or hyperglycemic clamp', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Christoph Stettler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}}}}