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

Not Applicable

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: rice-richen meal; Other: wheaten-richen meal

• Registration Number: NCT03550963
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11
• Study Start: 2018-06-23
• Primary Completion: 2018-11-23
• Study Completion: 2019-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rice-richen meal	rice-richen meal	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.
wheaten-richen meal	wheaten-richen meal	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.

Primary Outcome Measures

Name	Time	Method
between-group difference in glucose control	16 weeks	comparison of the percentage of desired glucose status between two groups

Secondary Outcome Measures

Name	Time	Method
between-group difference in undesirable clinical outcome	20 weeks	comparison of incidence of macrosomia, dystocia, etc.