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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: rice-richen meal; Other: wheaten-richen meal

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanping Liu, master; Phone Number: +861069159081; Email: liuyp1227@vip.sina.com
• Study Contact Backup: Name: Fang Wang, master; Phone Number: +8615201646084; Email: yours.fang@Hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
between-group difference in glucose control	comparison of the percentage of desired glucose status between two groups	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
between-group difference in undesirable clinical outcome	comparison of incidence of macrosomia, dystocia, etc.	20 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yanping Liu, master, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 23, 2018
• Primary Completion (Anticipated): November 23, 2018
• Study Completion (Anticipated): February 23, 2019

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: JS-1012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No