GDMNCT04930276
Diet-glucose-gut Microbiome Net in Women With GDM
A study testing Diet intervention in people with GDM and Blood Glucose, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A prospective cohort study was conducted to :1. explore the effective of diet intervention on blood glucose control; 2. observe the changeable composition of microbiota; 3. seek the possible microbiome intervened to prevent GDM. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- GDM, Blood Glucose, Pregnancy Outcome
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2021to 1 Apr 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who can have a regular labor inspection and delivery in the labor inspection hospital;
- The range of age is between 18 to 45 years;
- Pregnancy naturally and singleton pregnancy;
- Pregnant women with or without gestational diabetes diagnosed by oral glucose tolerance test at 24 to 28 weeks of pregnancy;
- Those who can skillfully use social software in mobile phones and obey the plan of follow-ups;
- Those who voluntary signing of informing consent.
Who cannot join
- Patients with pre-pregnancy diabetes or abnormal oral glucose tolerance test screening in early resulting from high risks or known pre-pregnancy glucose intolerance;
- Those who were estimated by endocrinology that their value of blood glucose is controlled by not only diet interventions but also drugs;
- Pregnant women who used antibiotics before 1 month enrollment ;
- Those who combined some metabolic diseases, such as hematological system diseases and nervous system diseases;
- Those who reject signing inform consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ob gyn , Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Liangkun Ma, MD, 13021961166, MaLiangKun@pumch.cn
Ying Tian, 13121591988, 1220325578@qq.com
About this study
Official title: The Impact of Diet-controlled Blood Glucose on Gut Microbiome in Women With Diabetes Mellitus
A prospective cohort study was conducted to :1. explore the effective of diet intervention on blood glucose control; 2. observe the changeable composition of microbiota; 3. seek the possible microbiome intervened to prevent GDM.
Read the detailed description
- Gestational diabetes mellitus（GDM） is one of the most complications during pregnancy and it is associated with many adverse outcomes for both mother and children in short or long term. Appropriate nutritional intervention is beneficial for the control of blood glucose. However, the strategy of intervention and mechanism remain uncertain. Previous studies have shown that diet maybe influence blood glucose via effecting the composition of gut microbiome. Recently, most studies collect only one sample and combine with the diet review, which have some limitations in revealing the effect of diet on gut microbiota and the process of change in blood glucose. This study aims to achieve the target of controlling blood glucose via diet intervention, which includes staple food distribution, food list and nutritional advice, describe the change of gut microbiota in women with GDM before and after the intervention via amplicon sequencing, estimate the effectiveness of diet intervention on controlling blood glucose and explore the correlation between the level of blood glucose and transition of bacterial diversity by monitoring blood glucose and glycated hemoglobin. Furthermore, explore the mechanism of "diet-bacterial diversity-blood glucose". Investigators hope deeply understand the mechanism of controlling blood glucose via diet intervention and find the effective diet control, probable bacterial intervention, which may be applied in clinical practice.This project is a prospective cohort study designed to explore the effect of diet to control blood glucose on the composition of gut microbiota in women with GDM.
- The study aims to enroll 50 participants with GDM and 20 participants with non-GDM. They will be provided with medical nutritional intervention and need to collect stool samples before and after intervention, separately. Nutritional professionals provide nutritional suggestions to manage blood glucose via examining food diary . All participants need exam glycated hemoglobin every two weeks and monitor fast blood glucose and 2 hour postprandial blood glucose in a one day. Total times of monitoring blood glucose is at least three times every week. Researchers record the situation of blood glucose both groups. Besides, participants need collect stool sample at 28 weeks (before the intervention) and 32 weeks (after the intervention), respectively. Samples will be sequenced by amplicon to describe the effects of diet intervention on the gut microbiome.
- Conditions
- GDM, Blood Glucose, Pregnancy Outcome, Microbiota
- Being tested
- Diet intervention
- Keywords
- GDM, diet intervention, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionOther
Professionals will guide participants to have a standard diet and require them to monitor blood glucose by themselves.
| Study group | Role | What they receive |
|---|---|---|
| GDM group | Experimental | After participants are enrolled, they would be given medical nutrient treatment. Besides, they need have a follow-up visit every two weeks. Blood glucose, body weight, lifestyle and clinical information are collected. Blood samples and stool samples are collected in 28 and 32 pregnant weeks, respectively. Receives: Other: Diet intervention |
| non-GDM group | Other | After participants enrollment, they also would be given medical nutrient treatment. And the other conditions are same as the group of GDM. Receives: Other: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Fast blood glucose and glycemic albumin will be combined to evaluate the efficiency of blood glucose control
Measured: From enrollment to delivery
the composition of gut microbiome
the composition of gut microbiome in women with GDM and non-GDM
Measured: From enrollment to delivery
the glycemic qualification rate
the frequency of ideal blood glucose values when participants monitor blood glucose by themselves every during every two weeks
Measured: From enrollment to delivery
Secondary outcomes (1)
pregnancy outcome
the occurrence of pre-eclampsia , gestational hypertension, macrosomia
Measured: during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start5 Mar 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Chinese Academic of Medical Science & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930276
- Sponsor's protocol ID
- JS-2842
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Diet-controlled Blood Glucose on Gut Microbiome in Women With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04930276
- Acronym / sponsor ID
- JS-2842
- Conditions
- GDM, Blood Glucose, Pregnancy Outcome, Microbiota
- Keywords
- GDM, diet intervention, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 18 Jun 2021 (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.
A prospective cohort study was conducted to :1. explore the effective of diet intervention on blood glucose control; 2. observe the changeable composition of microbiota; 3. seek the possible microbiome intervened to prevent GDM.
Detailed description
- Gestational diabetes mellitus（GDM） is one of the most complications during pregnancy and it is associated with many adverse outcomes for both mother and children in short or long term. Appropriate nutritional intervention is beneficial for the control of blood glucose. However, the strategy of intervention and mechanism remain uncertain. Previous studies have shown that diet maybe influence blood glucose via effecting the composition of gut microbiome. Recently, most studies collect only one sample and combine with the diet review, which have some limitations in revealing the effect of diet on gut microbiota and the process of change in blood glucose. This study aims to achieve the target of controlling blood glucose via diet intervention, which includes staple food distribution, food list and nutritional advice, describe the change of gut microbiota in women with GDM before and after the intervention via amplicon sequencing, estimate the effectiveness of diet intervention on controlling blood glucose and explore the correlation between the level of blood glucose and transition of bacterial diversity by monitoring blood glucose and glycated hemoglobin. Furthermore, explore the mechanism of "diet-bacterial diversity-blood glucose". Investigators hope deeply understand the mechanism of controlling blood glucose via diet intervention and find the effective diet control, probable bacterial intervention, which may be applied in clinical practice.This project is a prospective cohort study designed to explore the effect of diet to control blood glucose on the composition of gut microbiota in women with GDM.
- The study aims to enroll 50 participants with GDM and 20 participants with non-GDM. They will be provided with medical nutritional intervention and need to collect stool samples before and after intervention, separately. Nutritional professionals provide nutritional suggestions to manage blood glucose via examining food diary . All participants need exam glycated hemoglobin every two weeks and monitor fast blood glucose and 2 hour postprandial blood glucose in a one day. Total times of monitoring blood glucose is at least three times every week. Researchers record the situation of blood glucose both groups. Besides, participants need collect stool sample at 28 weeks (before the intervention) and 32 weeks (after the intervention), respectively. Samples will be sequenced by amplicon to describe the effects of diet intervention on the gut microbiome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM group | Experimental | Other: Diet interventionAfter participants are enrolled, they would be given medical nutrient treatment. Besides, they need have a follow-up visit every two weeks. Blood glucose, body weight, lifestyle and clinical information are collected. Blood samples and stool samples are collected in 28 and 32 pregnant weeks, respectively. |
| non-GDM group | Other | Other: Diet interventionAfter participants enrollment, they also would be given medical nutrient treatment. And the other conditions are same as the group of GDM. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women who can have a regular labor inspection and delivery in the labor inspection hospital;
- The range of age is between 18 to 45 years;
- Pregnancy naturally and singleton pregnancy;
- Pregnant women with or without gestational diabetes diagnosed by oral glucose tolerance test at 24 to 28 weeks of pregnancy;
- Those who can skillfully use social software in mobile phones and obey the plan of follow-ups;
Key exclusion criteria (5 listed)
- Patients with pre-pregnancy diabetes or abnormal oral glucose tolerance test screening in early resulting from high risks or known pre-pregnancy glucose intolerance;
- Those who were estimated by endocrinology that their value of blood glucose is controlled by not only diet interventions but also drugs;
- Pregnant women who used antibiotics before 1 month enrollment ;
- Those who combined some metabolic diseases, such as hematological system diseases and nervous system diseases;
- Those who reject signing inform consent.
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 |
|---|---|---|
| Diet interventionProfessionals will guide participants to have a standard diet and require them to monitor blood glucose by themselves. | Other | GDM group, non-GDM group |
Primary outcome
blood glucose
Time frame: From enrollment to delivery
Fast blood glucose and glycemic albumin will be combined to evaluate the efficiency of blood glucose control
the composition of gut microbiome
Time frame: From enrollment to delivery
the composition of gut microbiome in women with GDM and non-GDM
the glycemic qualification rate
Time frame: From enrollment to delivery
the frequency of ideal blood glucose values when participants monitor blood glucose by themselves every during every two weeks
1 secondary outcome
pregnancy outcome
Time frame: during delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for GDM
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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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.
Liangkun Ma study chair
Chinese Academic of Medical Science & Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with GDM and Blood Glucose, run by Peking Union Medical College Hospital at 1 site in China.
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 6 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Liangkun Ma (13021961166, MaLiangKun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: From enrollment to delivery). The study lists 3 primary outcomes in all. 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 18 Jun 2021.