Gestational Diabetes Mellitus in PregnancyNCT04801485
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
A study testing D-chiro inositol in people with Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- D-chiro inositol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 May 2023
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- During 12-16 weeks gestation
- Meet any of the following: prepregnancy BMI > 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
- Willing to participate
Who cannot join
- Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
- Multiple gestation
- Mental or cognitive impairment cannot complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China
Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.
- Being tested
- D-chiro inositol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro inositolDietary supplement
Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.
PlaceboDietary supplement
Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT.
| Study group | Role | What they receive |
|---|---|---|
| D-chiro inositol | Active comparator | 500 mg twice a day Receives: Dietary Supplement: D-chiro inositol |
| Placebo | Placebo comparator | 500 mg twice a day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of gestational diabetes
The number of cases and incidence of gestational diabetes according to OGTT
Measured: 24-28th weeks gestation
Secondary outcomes (3)
the perinatal outcomes-1
the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)
Measured: Delivery
the perinatal outcomes-2
weight gain during pregnancy (kg)
Measured: Delivery
the perinatal outcomes-3
the Caesarean-section incidence (%)
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Nov 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Quzhou Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801485
- Sponsor's protocol ID
- IRB-20190035-R
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Du Z, Zhang Z, Chen D. D-Chiro Inositol Supplementation and the Occurrence of Gestational Diabetes: A Randomized Controlled Trial in China. Food Sci Nutr. 2024 Dec 5;13(1):e4601. doi: 10.1002/fsn3.4601. eCollection 2025 Jan.
PubMed 39803251
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China
- ClinicalTrials.gov ID
- NCT04801485
- Acronym / sponsor ID
- IRB-20190035-R
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Quzhou Maternity and Child Health Care Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 17 Mar 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.
Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-chiro inositol | Active comparator | Dietary Supplement: D-chiro inositol500 mg twice a day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo500 mg twice a day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- During 12-16 weeks gestation
- Meet any of the following: prepregnancy BMI > 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
- Willing to participate
Key exclusion criteria (3 listed)
- Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
- Multiple gestation
- Mental or cognitive impairment cannot complete the study
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 |
|---|---|---|
| D-chiro inositolActive group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT. | Dietary supplement | D-chiro inositol |
| PlaceboPlacebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT. | Dietary supplement | Placebo |
Primary outcome
the incidence of gestational diabetes
Time frame: 24-28th weeks gestation
The number of cases and incidence of gestational diabetes according to OGTT
3 secondary outcomes
the perinatal outcomes-1
Time frame: Delivery
the perinatal outcomes-2
Time frame: Delivery
the perinatal outcomes-3
Time frame: Delivery
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 17 Apr 2025.
- Background: PubMed 39803251Chen X, Du Z, Zhang Z, Chen D. D-Chiro Inositol Supplementation and the Occurrence of Gestational Diabetes: A Randomized Controlled Trial in China. Food Sci Nutr. 2024 Dec 5;13(1):e4601. doi: 10.1002/fsn3.4601. eCollection 2025 Jan.
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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.
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 D-chiro inositol in people with Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang 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 3 inclusion and 3 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 17 Apr 2025. 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. Some participants in this study may receive a placebo. 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 (time frame: 24-28th weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801485, which also lists 1 linked publication.
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 17 Apr 2025.