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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Other: rice-richen meal; Other: wheaten-richen meal

Study type: Interventional

Funder types: Other

Identifiers

NCT03550963

JS-1012

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

rice-richen meal

Other group

Description:

All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group. The intervention of group one is that participants will be provided with rice-richen meal, meaning most of the calculated carbohydrates are from rice.

Treatment:

Other: rice-richen meal

wheaten-richen meal

Other group

Description:

All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group.The intervention of group two is that participants will be provided with wheaten-richen meal, meaning most of the calculated carbohydrates are from wheaten.

Treatment:

Other: wheaten-richen meal