Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Research on Comparison Between Rice-richen Meal and Wheaten-richen Meal on Glucose Control Status Among Chinese Women With GDM

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03550963
• Other study ID #: JS-1012
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 23, 2018
• Est. completion date: February 23, 2019

Study information

• Verified date: May 2018
• Source: gwcmc
• Contact: Yanping Liu, master
• Phone: +861069159081
• Email: liuyp1227[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since the prevalence of gestational diabetes melitus (GDM) increased by ..., as an important part of medical treatment, nutrition therapy is highly required to help patients achieve normoglycemia. Carbohydrate intake is the primary nutrient affecting postprandial glucose levels,therefore the total amount and type of carbohydrate should be manipulated to blunt postprandial hyperglycemia. However,the type of carbohydrate has not yet been established. Rice and wheaten food have similar Glycemic Index (GI),but some researches found the glucose response to them is different. A case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 23, 2019
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women who undergo health examination in obstetric department in Peking Union Medical College Hospital.

• 20-45 years old.

• Pregnant women who are diagnosed with GDM according to the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria during 24-28 weeks.

• Be ability to use mobile medical equipment, conditional follow-up of the mother and child.

• Voluntary participation in this study.

Exclusion Criteria:

• Multiple pregnancy.

• Merger of serious diseases (such as hypertension, respiratory diseases, kidney disease, abnormal coagulation, immune system diseases, infectious diseases), history of adverse pregnancy (such as spontaneous abortion, habitual abortion), and history of GDM.

• Pregnant women with known diabetes before pregnancy, those requiring insulin or hormone therapy.

• Pregnant women who are deemed inappropriate to participate in this clinical study by her physician.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• rice-richen meal
Participants in group one will be provided with rice-richen meal. All participants will be required to test and record blood glucose.
• wheaten-richen meal
Participants in group two will be provided with wheaten-richen meal.All participants will be required to test and record blood glucose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
gwcmc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	between-group difference in glucose control	comparison of the percentage of desired glucose status between two groups	16 weeks
Secondary	between-group difference in undesirable clinical outcome	comparison of incidence of macrosomia, dystocia, etc.	20 weeks