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Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03062475
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Wang Chen, Peking University First Hospital

Brief Summary:
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus (GDM) Behavioral: lifestyle intervention with dietary and exercise recommendation Not Applicable

Detailed Description:
Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lifestyle intervention group
Pregnant women allocated to this group receive lifestyle intervention. With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake. With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed or encourage them to do moderate cycling.
Behavioral: lifestyle intervention with dietary and exercise recommendation

With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake.For example we suggested exchanging carbohydrate-rich foods with a medium-to-high glycaemic index for those with a lower glycaemic index to reduce the glycaemic load, and restricting dietary intake of saturated fat.

With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed, or encourage them to do moderate cycling during pregnancy.


No Intervention: control group
Pregnant women allocated to this group receive standard prenatal care.



Primary Outcome Measures :
  1. GDM [ Time Frame: 24-28 gestational weeks ]
    According to the new criteria amended in August 2014 in China, GDM was diagnosed when any one value reaches or exceeds 5.1 mmol/L at 0 hours, 10.0 mmol/L at 1 hour, or 8.5 mmol/L at 2 hours. Values of 7.0 mmol/L at 0 hours or 11.1 mmol/L at 2 hours were diagnosed as DM, regardless of the pregnancy stage


Secondary Outcome Measures :
  1. birth weight [ Time Frame: up to 43 gestational weeks ]
    birth weight measured after baby was delivered and accurate to 0.1 kg

  2. gestational weeks [ Time Frame: up to 43 gestational weeks ]
    record the gestational weeks for delivery

  3. delivery mode [ Time Frame: up to 43 gestational weeks ]
    this includes vaginal delivery, operative vaginal delivery or cesarean delivery

  4. macrosomia [ Time Frame: up to 43 gestational weeks ]
    birth weight above 4000.0 g

  5. LGA [ Time Frame: up to 43 gestational weeks ]
    birth weight above the 90th percentile for gestational age

  6. SGA [ Time Frame: up to 43 gestational weeks ]
    birth weight below the 10th percentile for gestational age

  7. gestational hypertention [ Time Frame: up to 43 gestational weeks ]
    defined as blood pressure elevation [systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg] after 20 weeks gestation in the absence of proteinuria

  8. pre-eclampsia [ Time Frame: up to 43 gestational weeks ]
    defined as new-onset hypertension [systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg] and new-onset proteinuria [300 mg of protein in 24 hours or a urine protein/creatinine ratio of 0.3 mg/dL] after 20 weeks gestation or, in the absence of proteinuria, new-onset hypertension with new-onset thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual disturbances



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton;
  • non-smoking ;
  • before 12+6 weeks gestation.

Exclusion Criteria:

  • less than 18 years old;
  • unwilling to provide informed consent;
  • cervical insufficiency;
  • women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
  • women who were currently being treated with metformin or corticosteroids.

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): NCT03062475


Contacts
Contact: Chen Wang 18518079870 kisskissy22@126.com
Contact: Yumei Wei 18601369529 weiyumei1982@126.com

Sponsors and Collaborators
Peking University First Hospital

Responsible Party: Wang Chen, Principle investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03062475     History of Changes
Other Study ID Numbers: 20170226
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Recurrence
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Pregnancy Complications