Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) Clinical Trial

Official title:

The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062475
• Other study ID #: 20170226
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2019
• Source: Peking University First Hospital
• Contact: Chen Wang
• Phone: 18518079870
• Email: kisskissy22[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDM	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	24-28 gestational weeks
Secondary	birth weight	birth weight measured after baby was delivered and accurate to 0.1 kg	up to 43 gestational weeks
Secondary	gestational weeks	record the gestational weeks for delivery	up to 43 gestational weeks
Secondary	delivery mode	this includes vaginal delivery, operative vaginal delivery or cesarean delivery	up to 43 gestational weeks
Secondary	macrosomia	birth weight above 4000.0 g	up to 43 gestational weeks
Secondary	LGA	birth weight above the 90th percentile for gestational age	up to 43 gestational weeks
Secondary	SGA	birth weight below the 10th percentile for gestational age	up to 43 gestational weeks
Secondary	gestational hypertention	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	up to 43 gestational weeks
Secondary	pre-eclampsia	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	up to 43 gestational weeks