Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-28 @ 3:15 AM
Study NCT ID:
NCT05346250
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2022-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of type 2 diabetes', 'timeFrame': '10 years since randomization', 'description': 'The occurrence of diabetes at 2- and 10-year follow-up'}], 'secondaryOutcomes': [{'measure': 'Body weight change', 'timeFrame': '10 years since randomization', 'description': 'Body weight change at 2 and 10 year follow-up'}, {'measure': 'Blood pressure change', 'timeFrame': '10 years since randomization', 'description': 'Systolic and diastolic blood pressure at 2- and 10-year follow-up'}, {'measure': 'Serum lipid change', 'timeFrame': '10 years since randomization', 'description': 'Serum triglyceride, LDL-c levels at 2- and 10- year follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Obesity'], 'conditions': ['Type 2 Diabetes', 'Obesity, Abdominal']}, 'referencesModule': {'references': [{'pmid': '27379904', 'type': 'RESULT', 'citation': 'Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.'}, {'pmid': '27761987', 'type': 'RESULT', 'citation': 'Zhang HJ, Pan LL, Ma ZM, Chen Z, Huang ZF, Sun Q, Lu Y, Han CK, Lin MZ, Li XJ, Yang SY, Li XY. Long-term effect of exercise on improving fatty liver and cardiovascular risk factors in obese adults: A 1-year follow-up study. Diabetes Obes Metab. 2017 Feb;19(2):284-289. doi: 10.1111/dom.12809. Epub 2016 Nov 22.'}, {'pmid': '23665283', 'type': 'RESULT', 'citation': 'Zhang HJ, Zhang XF, Ma ZM, Pan LL, Chen Z, Han HW, Han CK, Zhuang XJ, Lu Y, Li XJ, Yang SY, Li XY. Irisin is inversely associated with intrahepatic triglyceride contents in obese adults. J Hepatol. 2013 Sep;59(3):557-62. doi: 10.1016/j.jhep.2013.04.030. Epub 2013 May 9.'}, {'pmid': '36716009', 'type': 'DERIVED', 'citation': 'Chen Y, Chen Z, Pan L, Ma ZM, Zhang H, Li XJ, Li X. Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults With Obesity: A 10-Year Follow-up of a Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):272-275. doi: 10.1001/jamainternmed.2022.6291.'}]}, 'descriptionModule': {'briefSummary': 'Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.', 'detailedDescription': 'Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants in our study included all subjects who had been enrolled in the previous randomized controlled trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);\n2. 40-65 years old;\n3. Waist circumference \\>90cm for men and \\>85cm for women\n\nExclusion criteria\n\n1. Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;\n2. A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;\n3. Myocardial infarction in the past six months;\n4. Biliary obstructive diseases;\n5. Uncontrolled hypertension (i.e. systolic BP\\>180 mmHg, and/or diastolic DBP \\>100 mmHg);\n6. Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);\n7. Heart failure (New York Heart Association III or IV);\n8. Currently participating in weight loss programs;\n9. Currently pregnant or planning to be pregnant;\n10. Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);\n11. Having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers);\n12. Unable to participate in the follow-up examination.'}, 'identificationModule': {'nctId': 'NCT05346250', 'briefTitle': 'Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Effect of Moderate and Vigorous Exercise on Incident Diabetes in Central Obese Subjects: a 10-year Follow-up Study', 'orgStudyIdInfo': {'id': 'CCEMD011V2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non exercise program', 'description': 'Subjects receive 12 month lifestyle education alone.', 'interventionNames': ['Behavioral: Non-exercise control']}, {'label': 'Moderate intensity exercise program', 'description': 'Subjects receive 12 month moderate exercise.', 'interventionNames': ['Behavioral: Moderate intensity exercise']}, {'label': 'Vigorous intensity exercise program', 'description': 'Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise', 'interventionNames': ['Behavioral: Vigorous intensity exercise']}], 'interventions': [{'name': 'Non-exercise control', 'type': 'BEHAVIORAL', 'description': '12 month lifestyle education', 'armGroupLabels': ['Non exercise program']}, {'name': 'Moderate intensity exercise', 'type': 'BEHAVIORAL', 'description': '12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.', 'armGroupLabels': ['Moderate intensity exercise program']}, {'name': 'Vigorous intensity exercise', 'type': 'BEHAVIORAL', 'description': '6 month vigorous intensity exercise on treadmill for 30 min per day and more than 5 days per week, and subsequent 6 month moderate exercise by brisk walk 30 min per day and more than 5 days per week.', 'armGroupLabels': ['Vigorous intensity exercise program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xiaoying Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2023-01\\~2025-01', 'ipdSharing': 'YES', 'description': 'deidentified data will be available after approval of the proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoying Li', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}