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

NCT03550963 | Unknown

• 1 other identifier: JS-1012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• between-group difference in glucose control

  comparison of the percentage of desired glucose status between two groups

  16 weeks

Secondary Outcomes (1)

• between-group difference in undesirable clinical outcome

  20 weeks

Study Arms (2)

rice-richen meal

OTHER

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

wheaten-richen meal

OTHER

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

Interventions

rice-richen meal OTHER

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

rice-richen meal

wheaten-richen meal OTHER

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

wheaten-richen meal

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Study participants will be recruited from pregnant women who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Officials

• Yanping Liu, master

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Liu, master

CONTACT

+861069159081; liuyp1227@vip.sina.com

Fang Wang, master

CONTACT

+8615201646084; yours.fang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: June 23, 2018
• Primary Completion: November 23, 2018
• Study Completion: February 23, 2019
• Last Updated: June 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share