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Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Tianjin Women and Children's Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
HunKun Liu, Tianjin Women and Children's Health Center
ClinicalTrials.gov Identifier:
NCT01554358
First received: December 13, 2011
Last updated: March 12, 2012
Last verified: March 2012

December 13, 2011
March 12, 2012
August 2009
July 2011   (final data collection date for primary outcome measure)
incident type 2 diabetes [ Time Frame: during 2-year follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01554358 on ClinicalTrials.gov Archive Site
approximately 40 SNPs [ Time Frame: during 2-year follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tianjin Gestational Diabetes Prevention Program (TGDPP)
Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)

A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 have and continues to be randomly assigned to either the intervention group or the control group. 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 six 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Gestational Diabetes Mellitus (GDM)
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) saturated fat intake <10% of energy consumed, 4) carbohydrate intake 55-65% of energy consumed, 5) fiber intake 20-30g per day, and 6) moderate or vigorous exercise for at least 30 min daily, seven days each week.

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  • 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) saturated fat intake <10% of energy consumed, 4) carbohydrate intake 55-65% of energy consumed, 5) fiber intake 20-30g per day, and 6) moderate or vigorous exercise for at least 30 min daily, seven days each week.
    Intervention: Behavioral: Lifestyle intervention
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1180
Not Provided
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Female
20 Years to 49 Years
Yes
Contact: Huikun Liu, PhD 86 2258297935 huikun_liu@sina.com
China
 
NCT01554358
TWCHC09-01
Yes
HunKun Liu, Tianjin Women and Children's Health Center
HunKun Liu
Not Provided
Not Provided
Tianjin Women and Children's Health Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP