Clinical trial NCT03550963: Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)
Official title: Research on Comparison Between Rice-richen Meal and Wheaten-richen Meal on Glucose Control Status Among Chinese Women With GDM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants included in the study will be randomized assigned into one of two groups in parallel. Group one will be provided with rice-richen meal, while group two will be provided with wheaten-richen meal. All other factors, i.e. nutrition education, following-up, and physical activity will be the same between two groups.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: between-group difference in glucose control
timeFrame: 16 weeks
Secondary outcomes:
measure: between-group difference in undesirable clinical outcome
timeFrame: 20 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yanping Liu, master
role: PRINCIPAL_INVESTIGATOR
References: