- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554358
Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)
Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tianjin, China, 30070
- Tianjin Women's and Children's Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for mothers:
- Age 20-49 years
- Women diagnosed with GDM between 2005 and 2009.
Inclusion Criteria for children: age 1-5 years at baseline survey.
Exclusion Criteria:
- Age < 20 and ≥ 50 years
- Newly diagnosed diabetes in the screening visit
- The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial
- Unable or unwilling to give informed consent or communicate with study staff
- Currently pregnant, or planning to become pregnant in the next four years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lifestyle counseling
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.
|
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. -------------------------------------------------------------------------------- |
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incident type 2 diabetes
Time Frame: during 4-year follow-up
|
during 4-year follow-up
|
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Cardiovascular risk factors
Time Frame: 9 month
|
Patients with newly diagnosed diabetes in Aim 3
|
9 month
|
cardimetablic risk
Time Frame: During 4-year follow-up
|
Children in Aim 4
|
During 4-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
approximately 40 SNPs
Time Frame: during 4-year follow-up
|
during 4-year follow-up
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TWCHC09-01
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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