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Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)

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ClinicalTrials.gov Identifier: NCT01554358
Recruitment Status : Active, not recruiting
First Posted : March 14, 2012
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
HunKun Liu, Tianjin Women and Children's Health Center

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).

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus (GDM) Behavioral: Lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)
Study Start Date : August 2009
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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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.



Primary Outcome Measures :
  1. incident type 2 diabetes [ Time Frame: during 4-year follow-up ]
  2. Cardiovascular risk factors [ Time Frame: 9 month ]
    Patients with newly diagnosed diabetes in Aim 3

  3. cardimetablic risk [ Time Frame: During 4-year follow-up ]
    Children in Aim 4


Secondary Outcome Measures :
  1. approximately 40 SNPs [ Time Frame: during 4-year follow-up ]


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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554358


Locations
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China
Tianjin Women's and Children's Health Center
Tianjin, China, 30070
Sponsors and Collaborators
Tianjin Women and Children's Health Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HunKun Liu, Project co-investigator, Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier: NCT01554358     History of Changes
Other Study ID Numbers: TWCHC09-01
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Keywords provided by HunKun Liu, Tianjin Women and Children's Health Center:
Gestational diabetes mellitus
Lifestyle intervention
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications