Gestational Diabetes Mellitus in PregnancyNCT03550963
Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)
A study testing rice-richen meal and wheaten-richen meal in people with Gestational Diabetes Mellitus in Pregnancy, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- rice-richen meal and wheaten-richen meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2018to 23 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- rice-richen meal, wheaten-richen meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice-richen mealOther
Participants in group one will be provided with rice-richen meal. All participants will be required to test and record blood glucose.
wheaten-richen mealOther
Participants in group two will be provided with wheaten-richen meal.All participants will be required to test and record blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: wheaten-richen meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
between-group difference in glucose control
comparison of the percentage of desired glucose status between two groups
Measured: 16 weeks
Secondary outcomes (1)
between-group difference in undesirable clinical outcome
comparison of incidence of macrosomia, dystocia, etc.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start23 Jun 2018 (estimated)
- Primary completion23 Nov 2018 (estimated)
- Study completion23 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuyanping, Peking Union Medical College Hospital
- Investigators
- Yanping Liu, master, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550963
- Sponsor's protocol ID
- JS-1012
- Status last verified
- May 2018
- First submitted
- 29 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Comparison Between Rice-richen Meal and Wheaten-richen Meal on Glucose Control Status Among Chinese Women With GDM
- ClinicalTrials.gov ID
- NCT03550963
- Acronym / sponsor ID
- JS-1012
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 23 Jun 2018 (estimated)
- Primary completion
- 23 Nov 2018 (estimated)
- Study completion
- 23 Feb 2019 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| rice-richen meal | Other | Other: rice-richen mealAll 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 | Other | Other: wheaten-richen mealAll 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rice-richen mealParticipants in group one will be provided with rice-richen meal. All participants will be required to test and record blood glucose. | Other | rice-richen meal |
| wheaten-richen mealParticipants in group two will be provided with wheaten-richen meal.All participants will be required to test and record blood glucose. | Other | wheaten-richen meal |
Primary outcome
between-group difference in glucose control
Time frame: 16 weeks
comparison of the percentage of desired glucose status between two groups
1 secondary outcome
between-group difference in undesirable clinical outcome
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanping Liu, master principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing rice-richen meal and wheaten-richen meal in people with Gestational Diabetes Mellitus in Pregnancy, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Liu, master (+861069159081, liuyp1227@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between-group difference in glucose control (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.