Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study

Diabetes, Gestational Clinical Trial

Official title:

Individualized Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893072
• Other study ID #: YYK-2016-002
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: The Third Xiangya Hospital of Central South University
• Contact: Min Liu, M.D.
• Phone: 86-731-88618717
• Email: liumin330[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. The overall purpose of this study is to determine the efficacy of individualized medical nutrition therapy (MNT) intervention to reduce and control the development of GDM.

Description:

The number of women with gestational diabetes mellitus had been increasing. Maternal GDM has a great impact on both the health of the mothers and the offspring. Antenatal lifestyle interventions, in particular dietary intervention appear to be feasible to improve maternal GDM and weight gain. To the best of our knowledge, there has been no such trial examining the feasibility of MNT intervention in pregnant women in Hu'nan province. The aim of this study is to evaluate the efficacy of individualized MNT intervention to reduce and control the development of GDM. This is a prospective study, 500 patients who meet inclusion and exclusion criteria will be included. The changes of glucose and weight will be evaluated every two weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women with gestational diabetes

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• Individualized medical nutrition therapy
The intervention group involves dietary and exercise advice and monitoring.

Locations

Country	Name	City	State
China	the Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intravenous glucose	Investigators will measure the participants' intravenous glucose every two weeks.From date of randomization until the date of parturition,assessed up to 10 months.	every two weeks, from date of randomization until the date of parturition, assessed up to 10 months