Gestational Diabetes MellitusNCT04190511
Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy
A study testing Prebiotic-containing dairy and Dietary intervention in people with Gestational Diabetes Mellitus and Medical Nutrition Therapy, run by Capital Medical University at 1 site in China.
Trial summary
Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Medical Nutrition Therapy, Overweight/Obese
- What is being tested?
- Prebiotic-containing dairy and Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to 31 Dec 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 ~ 45 years
- single pregnancy
- enrollment week 8-12 + 6 weeks (based on the last menstrual period or B-ultrasound monitoring)
- BMI ≥ 25 kg / m2
- living in Beijing for at least 5 years
Who cannot join
- Taking antibiotics, probiotics or prebiotics
- smoking regularly
- drinking alcohol
- assisted fertility technology conception
- mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys
- history of bariatric surgery
Show all 10Show fewer
- not following dietary recommendations
- Lactose intolerance
- milk protein allergy
- pre-pregnancy hypertension, diabetes, Hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and a history of infectious diseases (hepatitis, tuberculosis, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Chaoyang, 100026
About this study
Official title: Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort
Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.
- Conditions
- Gestational Diabetes Mellitus, Medical Nutrition Therapy, Overweight/Obese, Gut Microbiota, Adverse Pregnancy Outcomes
- Being tested
- Prebiotic-containing dairy, Dietary intervention
- Medical subject headings
- Diabetes, Gestational, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic-containing dairyDietary supplement
The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).
Dietary interventionDietary supplement
The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic-containing dairy intervention group | Experimental | Not described Receives: Dietary Supplement: Prebiotic-containing dairy; Dietary Supplement: Dietary intervention |
| Dietary intervention group | Active comparator | Not described Receives: Dietary Supplement: Dietary intervention |
| Conventional care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of gestational diabetes mellitus
The diagnose of GDM based on the result of OGTT according to IADPSG criterion in 24 to 28 weeks. We will compare the incidence of GDM in these three groups.
Measured: Up to 28 weeks
Weight change during pregnancy
We asked pregnant woman to weigh their weight using the same weighing scale in the morning of the inspection day after urinating and tell the obstetrician to record. Compare the weight gain during pregnancy among three groups.
Measured: During pregnancy, an average of 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start10 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghui Li, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190511
- Sponsor's protocol ID
- 2017-KY-015-01
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2019
- Last updated
- 2 Aug 2021
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort
- ClinicalTrials.gov ID
- NCT04190511
- Acronym / sponsor ID
- 2017-KY-015-01
- Conditions
- Gestational Diabetes Mellitus, Medical Nutrition Therapy, Overweight/Obese, Gut Microbiota, Adverse Pregnancy Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Dec 2019 (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 incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prebiotic-containing dairy intervention group | Experimental | Dietary Supplement: Prebiotic-containing dairy, Dietary Supplement: Dietary intervention |
| Dietary intervention group | Active comparator | Dietary Supplement: Dietary intervention |
| Conventional care group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 ~ 45 years
- single pregnancy
- enrollment week 8-12 + 6 weeks (based on the last menstrual period or B-ultrasound monitoring)
- BMI ≥ 25 kg / m2
- living in Beijing for at least 5 years
Key exclusion criteria (10 listed)
- Taking antibiotics, probiotics or prebiotics
- smoking regularly
- drinking alcohol
- assisted fertility technology conception
- mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys
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 |
|---|---|---|
| Prebiotic-containing dairyThe trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day). | Dietary supplement | Prebiotic-containing dairy intervention group |
| Dietary interventionThe trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. | Dietary supplement | Dietary intervention group, Prebiotic-containing dairy intervention group |
Primary outcome
The incidence of gestational diabetes mellitus
Time frame: Up to 28 weeks
The diagnose of GDM based on the result of OGTT according to IADPSG criterion in 24 to 28 weeks. We will compare the incidence of GDM in these three groups.
Weight change during pregnancy
Time frame: During pregnancy, an average of 38 weeks
We asked pregnant woman to weigh their weight using the same weighing scale in the morning of the inspection day after urinating and tell the obstetrician to record. Compare the weight gain during pregnancy among three groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
Related trials for Gestational Diabetes Mellitus
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 recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic-containing dairy and Dietary intervention in people with Gestational Diabetes Mellitus and Medical Nutrition Therapy, run by Capital Medical University 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 2 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gestational diabetes mellitus (time frame: Up to 28 weeks). The study lists 2 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 2 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.