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Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)

Primary Purpose

Gestational Diabetes Mellitus (GDM)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Tianjin Women and Children's Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus (GDM) focused on measuring Gestational diabetes mellitus, Lifestyle intervention

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tianjin Women's and Children's Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Lifestyle counseling

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

incident type 2 diabetes
Cardiovascular risk factors
Patients with newly diagnosed diabetes in Aim 3
cardimetablic risk
Children in Aim 4

Secondary Outcome Measures

approximately 40 SNPs

Full Information

First Posted
December 13, 2011
Last Updated
December 14, 2018
Sponsor
Tianjin Women and Children's Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01554358
Brief Title
Tianjin Gestational Diabetes Prevention Program (TGDPP)
Acronym
GDM
Official Title
Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Women and Children's Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus (GDM)
Keywords
Gestational diabetes mellitus, Lifestyle intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Other
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention 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. --------------------------------------------------------------------------------
Primary Outcome Measure Information:
Title
incident type 2 diabetes
Time Frame
during 4-year follow-up
Title
Cardiovascular risk factors
Description
Patients with newly diagnosed diabetes in Aim 3
Time Frame
9 month
Title
cardimetablic risk
Description
Children in Aim 4
Time Frame
During 4-year follow-up
Secondary Outcome Measure Information:
Title
approximately 40 SNPs
Time Frame
during 4-year follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tianjin Women's and Children's Health Center
City
Tianjin
ZIP/Postal Code
30070
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34337972
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.
Results Reference
derived
PubMed Identifier
31542245
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.
Results Reference
derived
PubMed Identifier
31271198
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.
Results Reference
derived

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Tianjin Gestational Diabetes Prevention Program (TGDPP)

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