Gestational DiabetesNCT03550976
The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
A study testing The low-GI diet and muscle training in people with Gestational Diabetes, run by Peking Union Medical College Hospital.
Trial summary
The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- The low-GI diet and muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Jun 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- early pregnant women (< 12 weeks)
- fasting blood glucose < / = 5.6 mmol/L and glycosylated hemoglobin < / = 5.6%
- prepregnancy overweight (BMI > 23.9) or body fat content more than 30% (based on body composition analysis)
- no history of major diseases or long-term drug treatment
- no obvious physical disabilities, the ability of physical activity is normal
- dietary behavior and mental is normal
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- resident in Beijing, early and middle stage pregnancy can be in Beijing area to receive regular obstetric examinations
- signed informed consent
- the following at least one
- first-degree relatives family history of diabetes
- history of abnormal lipid metabolism or abnormal lipid metabolism
- history of polycystic ovary syndrome
- history of large for gestational age infant or macrosomia deliver
Who cannot join
- history of gestational diabetes mellitus
- clinical glucose metabolism abnormalities
- once taking diabetes drugs or insulin injections
- a variety of food allergies or food choices serious limitations
- exercise during pregnancy contraindication
Trial locations and contacts
No sites are listed yet.
About this study
The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable way to predict and intervene early.This study is a randomized controlled trials, and aims to use comprehensive prediction method (genetic screening, body composition, clinical risk factors screening) screening the subjects with high GDM risk in early pregnancy, conducting diet and exercise intervention in second trimester and observing the effect on the incidence of GDM and perinatal outcomes.
- Conditions
- Gestational Diabetes
- Being tested
- The low-GI diet and muscle training
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The low-GI diet and muscle trainingBehavioural
During the 12-28 weeks of pregnancy, the pregnant women received low-GI diet and exercise intervention.Every two weeks, the pregnant women were followed up to assess the dietary situation and analyze the body composition results.Collect birth outcomes
| Study group | Role | What they receive |
|---|---|---|
| High risk intervention group | Experimental | Not described Receives: Behavioral: The low-GI diet and muscle training |
| High risk control group | No intervention | Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes. |
| Low risk control group | No intervention | Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gestational diabetes
The incidence of GDM was compared between the low-GI diet and the muscle training group, the high-risk control group and the low-risk control group.
Measured: 12-28 weeks of pregnancy
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 start1 Oct 2018 (estimated)
- Primary completion10 Sep 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550976
- Sponsor's protocol ID
- hs-1551
- Status last verified
- Aug 2018
- First submitted
- 29 May 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03550976
- Acronym / sponsor ID
- hs-1551
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 1 Jun 2020 (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.
The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable way to predict and intervene early.This study is a randomized controlled trials, and aims to use comprehensive prediction method (genetic screening, body composition, clinical risk factors screening) screening the subjects with high GDM risk in early pregnancy, conducting diet and exercise intervention in second trimester and observing the effect on the incidence of GDM and perinatal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk intervention group | Experimental | Behavioral: The low-GI diet and muscle training |
| High risk control group | No intervention | –Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes. |
| Low risk control group | No intervention | –Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- early pregnant women (< 12 weeks)
- fasting blood glucose < / = 5.6 mmol/L and glycosylated hemoglobin < / = 5.6%
- prepregnancy overweight (BMI > 23.9) or body fat content more than 30% (based on body composition analysis)
- no history of major diseases or long-term drug treatment
- no obvious physical disabilities, the ability of physical activity is normal
Key exclusion criteria (5 listed)
- history of gestational diabetes mellitus
- clinical glucose metabolism abnormalities
- once taking diabetes drugs or insulin injections
- a variety of food allergies or food choices serious limitations
- exercise during pregnancy contraindication
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 |
|---|---|---|
| The low-GI diet and muscle trainingDuring the 12-28 weeks of pregnancy, the pregnant women received low-GI diet and exercise intervention.Every two weeks, the pregnant women were followed up to assess the dietary situation and analyze the body composition results.Collect birth outcomes | Behavioural | High risk intervention group |
Primary outcome
Incidence of gestational diabetes
Time frame: 12-28 weeks of pregnancy
The incidence of GDM was compared between the low-GI diet and the muscle training group, the high-risk control group and the low-risk control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The low-GI diet and muscle training in people with Gestational Diabetes, 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 13 inclusion and 5 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 8 Aug 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 Yanpin Liu, bachelor (+861069159088, liuyp1227@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gestational diabetes (time frame: 12-28 weeks of pregnancy). 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 8 Aug 2018.