Clinical trial NCT01554358: Tianjin Gestational Diabetes Prevention Program (TGDPP)
Official title: Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: Gestational diabetes mellitus
Lifestyle intervention
Lead sponsor: Tianjin Women and Children's Health Center
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 2526
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria for mothers:

1. Age 20-49 years
2. Women diagnosed with GDM between 2005 and 2009.

Inclusion Criteria for children: age 1-5 years at baseline survey.

Exclusion Criteria:

1. Age \< 20 and ≥ 50 years
2. Newly diagnosed diabetes in the screening visit
3. The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial
4. Unable or unwilling to give informed consent or communicate with study staff
5. Currently pregnant, or planning to become pregnant in the next four years

Primary outcomes:
measure: incident type 2 diabetes
timeFrame: during 4-year follow-up
measure: Cardiovascular risk factors
timeFrame: 9 month
measure: cardimetablic risk
timeFrame: During 4-year follow-up
Secondary outcomes:
measure: approximately 40 SNPs
timeFrame: during 4-year follow-up
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Women's and Children's Health Center
Study officials:
References:
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.
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.
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.