Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01554358
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2011-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tianjin Gestational Diabetes Prevention Program (TGDPP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-23', 'releaseDate': '2024-07-26'}, {'resetDate': '2025-01-24', 'releaseDate': '2024-12-04'}], 'estimatedResultsFirstSubmitDate': '2024-07-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2526}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incident type 2 diabetes', 'timeFrame': 'during 4-year follow-up'}, {'measure': 'Cardiovascular risk factors', 'timeFrame': '9 month', 'description': 'Patients with newly diagnosed diabetes in Aim 3'}, {'measure': 'cardimetablic risk', 'timeFrame': 'During 4-year follow-up', 'description': 'Children in Aim 4'}], 'secondaryOutcomes': [{'measure': 'approximately 40 SNPs', 'timeFrame': 'during 4-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gestational diabetes mellitus', 'Lifestyle intervention'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'referencesModule': {'references': [{'pmid': '34337972', 'type': 'DERIVED', 'citation': 'Joyce BT, Liu H, Wang L, Wang J, Zheng Y, Nannini D, Drong A, Shiau S, Li W, Leng J, Shen Y, Gao R, Baccarelli A, Hu G, Hou L. Novel epigenetic link between gestational diabetes mellitus and macrosomia. Epigenomics. 2021 Aug;13(15):1221-1230. doi: 10.2217/epi-2021-0096. Epub 2021 Aug 2.'}, {'pmid': '31542245', 'type': 'DERIVED', 'citation': 'Liang Z, Wang L, Liu H, Chen Y, Zhou T, Heianza Y, Leng J, Li W, Yang X, Shen Y, Gao R, Hu G, Qi L. Genetic susceptibility, lifestyle intervention and glycemic changes among women with prior gestational diabetes. Clin Nutr. 2020 Jul;39(7):2144-2150. doi: 10.1016/j.clnu.2019.08.032. Epub 2019 Sep 10.'}, {'pmid': '31271198', 'type': 'DERIVED', 'citation': 'Chen Y, Liu H, Wang L, Zhou T, Liang Z, Li W, Shang X, Leng J, Shen Y, Hu G, Qi L. Lifestyle intervention modifies the effect of the MC4R genotype on changes in insulin resistance among women with prior gestational diabetes: Tianjin Gestational Diabetes Mellitus Prevention Program. Am J Clin Nutr. 2019 Sep 1;110(3):750-758. doi: 10.1093/ajcn/nqz121.'}]}, 'descriptionModule': {'briefSummary': "A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. A total of 83 women with prior GDM and newly diagnosed diabetes at baseline survey have the nine-month lifestyle intervention program. GDM women in the intervention group will have five consulting sessions with a dietician during the first year and two sessions during the second year. The intervention group are given detailed advice about how to achieve the five goals of the intervention. The primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes (T2D) in women with prior GDM. The second aim will test gene-intervention interactions through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation to metabolic traits for T2D in GDM women. The third aim will evaluate the effects of the nine-month lifestyle intervention program on cardiovascular risk factors in women with prior GDM and newly diagnosed diabetes. The forth aim will assess if a lifestyle intervention targeting both GDM mothers and their offspring can greatly improve offspring's cardimetablic risk (body weight, glucose and lipid metabolism)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for mothers:\n\n1. Age 20-49 years\n2. Women diagnosed with GDM between 2005 and 2009.\n\nInclusion Criteria for children: age 1-5 years at baseline survey.\n\nExclusion Criteria:\n\n1. Age \\< 20 and ≥ 50 years\n2. Newly diagnosed diabetes in the screening visit\n3. The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial\n4. Unable or unwilling to give informed consent or communicate with study staff\n5. Currently pregnant, or planning to become pregnant in the next four years'}, 'identificationModule': {'nctId': 'NCT01554358', 'acronym': 'GDM', 'briefTitle': 'Tianjin Gestational Diabetes Prevention Program (TGDPP)', 'organization': {'class': 'OTHER', 'fullName': "Tianjin Women and Children's Health Center"}, 'officialTitle': 'Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)', 'orgStudyIdInfo': {'id': 'TWCHC09-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lifestyle counseling', 'description': 'The women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake \\<30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'the subjects in the control group had been educated regarding general principles of healthy lifestyle that benefits T2D and obesity prevention, and also informed about the current evidence showing that the lifestyle intervention is effective in women at high risk for T2D during the "run-in" period.'}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'The women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake \\<30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.\n\n\\--------------------------------------------------------------------------------', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30070', 'city': 'Tianjin', 'country': 'China', 'facility': "Tianjin Women's and Children's Health Center", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Tianjin Women and Children's Health Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project co-investigator', 'investigatorFullName': 'HunKun Liu', 'investigatorAffiliation': "Tianjin Women and Children's Health Center"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-26', 'type': 'RELEASE'}, {'date': '2024-10-23', 'type': 'RESET'}, {'date': '2024-12-04', 'type': 'RELEASE'}, {'date': '2025-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': "HunKun Liu, Project co-investigator, Tianjin Women and Children's Health Center"}}}}