Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-06 @ 8:46 AM
Study NCT ID:
NCT02951260
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'AMPK-activation in skeletal muscle during an exercise bout with fixed intensity', 'timeFrame': 'change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity'}, {'measure': 'Oxidative phosphorylation in skeletal muscle fibers', 'timeFrame': 'Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment'}], 'primaryOutcomes': [{'measure': 'Overall aerobic work performed during an exercise bout with self-selected intensity', 'timeFrame': 'Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity'}], 'secondaryOutcomes': [{'measure': 'External work performed during an exercise bout with self-selected intensity', 'timeFrame': 'Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity'}, {'measure': 'Rate of perceived exertion during an exercise bout with fixed intensity', 'timeFrame': 'Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity'}, {'measure': 'blood lactate during an exercise bout with fixed intensity', 'timeFrame': 'Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity'}, {'measure': 'Heartrate during an exercise bout with fixed intensity', 'timeFrame': 'Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity'}, {'measure': 'Respiratory exchange ratio during an exercise bout with fixed intensity', 'timeFrame': 'Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity'}, {'measure': 'Physical fitness (VO2max)', 'timeFrame': 'maximal oxygen consumption (L/min) during a VO2 max test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34784247', 'type': 'DERIVED', 'citation': 'Pilmark NS, Oberholzer L, Halling JF, Kristensen JM, Bonding CP, Elkjaer I, Lyngbaek M, Elster G, Siebenmann C, Holm NFR, Birk JB, Larsen EL, Lundby AM, Wojtaszewski J, Pilegaard H, Poulsen HE, Pedersen BK, Hansen KB, Karstoft K. Skeletal muscle adaptations to exercise are not influenced by metformin treatment in humans: secondary analyses of 2 randomized, clinical trials. Appl Physiol Nutr Metab. 2022 Mar;47(3):309-320. doi: 10.1139/apnm-2021-0194. Epub 2021 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the potential interaction between metformin and exercise in order to optimize clinical guidelines for treatment of T2D.', 'detailedDescription': 'Physical activity is a first line treatment for patients with type 2 diabetes (T2D ), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. It is known that metformin and exercise both activates AMPK, which results in many different metabolic effects. Because of this similarity, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. With this study the investigators aim to look at the individual and combined effects of metformin and exercise in order to investigate whether an interaction occur. An Interaction will have tremendous clinical importance for patients with T2D given current guidelines where the vast majority of these patients are recommended both exercise and metformin treatment.\n\nThe investigators hypothesize that metformin treatment reduces self-selected exercise intensity, which may be explained via decreased mitochondrial complex 1 function, increased blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced AMPK-activation is reduced with metformin treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* HbA1c \\< 39 mmol/l\n* BMI \\< 25\n* structured physical activity \\< = 150 min/week\n* apparently healthy\n\nExclusion Criteria:\n\n* smoking\n* daily pharmaceutical treatment\n* contraindication to increased levels of physical activity\n* ALAT/ASAT elevated 3 times above upper normal values\n* renal insufficiency (eGFR \\< 60 ml/min)\n* prior history of lactic acidosis'}, 'identificationModule': {'nctId': 'NCT02951260', 'briefTitle': 'The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation', 'orgStudyIdInfo': {'id': 'H- 16032037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': '17 days metformin treatment', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '17 days placebo treatment', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': '17 days treatment with metformin', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '17 days treatment with placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Copenhagen N', 'country': 'Denmark', 'facility': 'Center for aktiv sundhed', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kristian Karstoft, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for aktiv sundhed, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Kristian Karstoft', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}