Tianjin Gestational Diabetes Prevention Program (TGDPP)

Gestational Diabetes Mellitus (GDM) Clinical Trial

— GDM  

Official title:

Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01554358
• Other study ID #: TWCHC09-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2009

Study information

• Verified date: December 2018
• Source: Tianjin Women and Children's Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2526
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus (GDM)

Intervention

Behavioral:
• Lifestyle intervention
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.

Locations

Country	Name	City	State
China	Tianjin Women's and Children's Health Center	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Women and Children's Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incident type 2 diabetes		during 4-year follow-up
Primary	Cardiovascular risk factors	Patients with newly diagnosed diabetes in Aim 3	9 month
Primary	cardimetablic risk	Children in Aim 4	During 4-year follow-up
Secondary	approximately 40 SNPs		during 4-year follow-up