Thyroid DysfunctionNCT05952739
Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort
An observational study of Thyroid Dysfunction and Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The incidence of metabolic diseases in pregnant women is increasing rapidly, and the risk of metabolic diseases in children is also increasing. However, there is a lack of early predictive indicators for metabolic diseases in children, which cannot effectively prevent and treat metabolic diseases in children. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Thyroid Dysfunction, Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to Sep 2025
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: Women with metabolic disease before or during pregnancy and control group
Who may be able to join
None listed.
Who cannot join
- Twin or multiple pregnancy
- Severe pregnancy complications
- Complicated with important heart, liver, kidney, blood system and autoimmune diseases before pregnancy
- Associated with other diseases that may affect intestinal flora or metabolomics, including inflammatory bowel disease, irritable bowel syndrome, celiac disease, etc.
- Gastrointestinal and biliary surgeries, including bariatric surgery and cholecystectomy
- History of smoking, alcoholism, narcotic drug use
- For women who keep stool samples: antibiotics within 2 months of specimen collection: probiotics within 1 week of specimen collection: take oral drugs that may affect intestinal flora.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, , China
Beijing, 100730
Xinhua Xiao
About this study
The incidence of metabolic diseases in pregnant women is increasing rapidly, and the risk of metabolic diseases in children is also increasing. However, there is a lack of early predictive indicators for metabolic diseases in children, which cannot effectively prevent and treat metabolic diseases in children. This project will establish a clinical database and a long-term follow-up biological bio-bank through the follow-up of metabolic indicators before and during pregnancy, and form an early warning system for the effects of maternal endocrine and metabolic diseases on the metabolism of offspring. It will not only help to warn the impact of maternal endocrine system and metabolic diseases on the metabolism of offspring, but also build a transformation platform for the study of maternal endocrine and metabolic diseases and metabolic health of offspring, which has important clinical value for curbing the rapid growth of metabolic diseases such as diabetes and obesity in China. It is expected to provide an important theoretical basis for the window period of prevention and treatment of endocrine and metabolic diseases in China.
Read the detailed description
Due to the rapid changes in the environment and lifestyle, women of childbearing age often suffer from endocrine and metabolic diseases such as diabetes and thyroid diseases, resulting in poor intrauterine development environment in the early life. Maternal endocrine metabolic diseases and nutritional status not only affect their own health, but also greatly affect the metabolic health of their offspring. Hyperglycemia and thyroid dysfunction during pregnancy can increase the risk of obesity, metabolic syndrome and diabetes in offspring. The developmental origin of health and disease (DOHaD) is a well-known theory about the effect of early developmental environment (fetus and newborn) on the metabolic health of offspring. Several well-known international birth cohorts have confirmed that maternal malnutrition during pregnancy can lead to an increased risk of metabolic diseases in adult offspring. Previously, Xiao 's team found that low birth weight was an independent risk factor for abnormal glucose and lipid metabolism in adulthood through the 'Concord birth-old age' cohort study, which confirmed the DOHaD theory for the first time in the Chinese population. The above retrospective cohort study provides epidemiological evidence for the DOHaD theory. However, due to its early start and the lack of a comprehensive database of clinical data and biological samples at different stages of the subjects' lives, it is difficult to deeply analyze the high-risk factors of metabolic abnormalities in offspring, and it is difficult to effectively intervene and block the 'origin of metabolic diseases' from the early stage of life development. In addition, cross-generational studies at home and abroad are mostly retrospective and cross-sectional studies, with selection bias and information bias. Prospective birth cohort studies covering the whole life cycle of maternal endocrine and metabolic diseases are urgently needed. This project will continue to focus on the endocrine system and metabolic diseases of women of childbearing age in this large birth cohort, and cooperate with the Department of Endocrinology, Obstetrics, Pediatrics and Nutrition of Peking Union Medical College Hospital to construct a large-scale prospective cohort of maternal endocrine and metabolic diseases in the whole pregnancy cycle, establish a clinical database and a long-term follow-up bio-bank, and form an early predictive system for the impact of maternal endocrine and metabolic diseases on the metabolism of offspring, so as to provide a scientific basis for comprehensively predicting the short-term and long-term metabolic trajectories of offspring.
- Conditions
- Thyroid Dysfunction, Diabetes Mellitus
- Keywords
- Hyperglycemia during pregnancy, Thyroid Dysfunction During Pregnancy, Offspring metabolic diseases
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease group | No interventions | |
| Control group | No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes mellitus
Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy
Measured: Measure blood glucose up to 28 weeks of pregnancy
Thyroid dysfunction during pregnancy
Slightly higher TSH or positive TPOAb; 140 participants with thyroid dysfunction during pregnancy
Measured: Measure thyroid function up to 28 weeks of pregnancy
Abnormal metabolism of offspring
Abnormal birth weight，blood sugar etc; 300 participants
Measured: 1 year
Diabetes mellitus complicating pregnancy
Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy
Measured: Measure blood glucose up to 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 posted19 Jul 2023
- Study start1 Aug 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Thyroid DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhua Xiao, Peking Union Medical College Hospital
- Investigators
- Xinhua Xiao, Study director, Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952739
- Sponsor's protocol ID
- 2022-PUMCH-C-019
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.
PubMed 34879977Osmond C, Barker DJ. Fetal, infant, and childhood growth are predictors of coronary heart disease, diabetes, and hypertension in adult men and women. Environ Health Perspect. 2000 Jun;108 Suppl 3(Suppl 3):545-53. doi: 10.1289/ehp.00108s3545.
PubMed 10852853Xiao X, Zhang ZX, Cohen HJ, Wang H, Li W, Wang T, Xu T, Liu A, Gai MY, Ying S, Schmitz O, Yi Z. Evidence of a relationship between infant birth weight and later diabetes and impaired glucose regulation in a Chinese population. Diabetes Care. 2008 Mar;31(3):483-7. doi: 10.2337/dc07-1130. Epub 2007 Dec 10.
PubMed 18070988Rawal S, Olsen SF, Grunnet LG, Ma RC, Hinkle SN, Granstrom C, Wu J, Yeung E, Mills JL, Zhu Y, Bao W, Ley SH, Hu FB, Damm P, Vaag A, Tsai MY, Zhang C. Gestational Diabetes Mellitus and Renal Function: A Prospective Study With 9- to 16-Year Follow-up After Pregnancy. Diabetes Care. 2018 Jul;41(7):1378-1384. doi: 10.2337/dc17-2629. Epub 2018 May 4.
PubMed 29728364Kooijman MN, Kruithof CJ, van Duijn CM, Duijts L, Franco OH, van IJzendoorn MH, de Jongste JC, Klaver CC, van der Lugt A, Mackenbach JP, Moll HA, Peeters RP, Raat H, Rings EH, Rivadeneira F, van der Schroeff MP, Steegers EA, Tiemeier H, Uitterlinden AG, Verhulst FC, Wolvius E, Felix JF, Jaddoe VW. The Generation R Study: design and cohort update 2017. Eur J Epidemiol. 2016 Dec;31(12):1243-1264. doi: 10.1007/s10654-016-0224-9. Epub 2017 Jan 9.
PubMed 28070760Lv H, Diao F, Du J, Chen T, Meng Q, Ling X, Li H, Song C, Xi Q, Jiang Y, Xu Y, Tao S, Huang L, Wen M, Peng M, Liu C, Lu Q, He Y, Yin Y, Liu X, Xu B, Han X, Zhou K, Jiang T, Zhao Y, Ma H, Jin G, Xia Y, Liu J, Lin Y, Hu Z, Shen H. Assisted reproductive technology and birth defects in a Chinese birth cohort study. Lancet Reg Health West Pac. 2021 Jan 22;7:100090. doi: 10.1016/j.lanwpc.2020.100090. eCollection 2021 Feb.
PubMed 34327418Wang YY, Li Q, Guo Y, Zhou H, Wang QM, Shen HP, Zhang YP, Yan DH, Li S, Chen G, Zhou S, He Y, Yang Y, Peng ZQ, Wang HJ, Ma X. Ambient temperature and the risk of preterm birth: A national birth cohort study in the mainland China. Environ Int. 2020 Sep;142:105851. doi: 10.1016/j.envint.2020.105851. Epub 2020 Jun 22.
PubMed 32585501Zhou L, Li S, Zhang Q, Yu M, Xiao X. Maternal Exercise Programs Glucose and Lipid Metabolism and Modulates Hepatic miRNAs in Adult Male Offspring. Front Nutr. 2022 Mar 1;9:853197. doi: 10.3389/fnut.2022.853197. eCollection 2022.
PubMed 35299765Liu J, Ding L, Zhai X, Wang D, Xiao C, Hui X, Sun T, Yu M, Zhang Q, Li M, Xiao X. Maternal Dietary Betaine Prevents High-Fat Diet-Induced Metabolic Disorders and Gut Microbiota Alterations in Mouse Dams and Offspring From Young to Adult. Front Microbiol. 2022 Apr 5;13:809642. doi: 10.3389/fmicb.2022.809642. eCollection 2022.
PubMed 35479641Zhang Q, Sun X, Xiao X, Zheng J, Li M, Yu M, Ping F, Wang Z, Qi C, Wang T, Wang X. The effect of maternal chromium status on lipid metabolism in female elderly mice offspring and involved molecular mechanism. Biosci Rep. 2017 Apr 28;37(2):BSR20160362. doi: 10.1042/BSR20160362. Print 2017 Apr 30.
PubMed 28320771Zhou L, Xiao X, Li M, Zhang Q, Yu M, Zheng J, Deng M. Maternal Exercise Improves High-Fat Diet-Induced Metabolic Abnormalities and Gut Microbiota Profiles in Mouse Dams and Offspring. Front Cell Infect Microbiol. 2020 Jun 17;10:292. doi: 10.3389/fcimb.2020.00292. eCollection 2020.
PubMed 32626663Zeng Y, Yu J, Ren Y, Ren J, Chen H, Zhang Q, Xiao X. Maternal Endocrine and Metabolic Health and Outcomes (MEMO): a prospective cohort study of gestational diabetes mellitus and subclinical hypothyroidism in China. BMC Pregnancy Childbirth. 2025 Dec 27;26(1):147. doi: 10.1186/s12884-025-08294-5.
PubMed 41455930
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort
- ClinicalTrials.gov ID
- NCT05952739
- Acronym / sponsor ID
- 2022-PUMCH-C-019
- Conditions
- Thyroid Dysfunction, Diabetes Mellitus
- Keywords
- Hyperglycemia during pregnancy, Thyroid Dysfunction During Pregnancy, Offspring metabolic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Jul 2023 (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 metabolic diseases in pregnant women is increasing rapidly, and the risk of metabolic diseases in children is also increasing. However, there is a lack of early predictive indicators for metabolic diseases in children, which cannot effectively prevent and treat metabolic diseases in children. This project will establish a clinical database and a long-term follow-up biological bio-bank through the follow-up of metabolic indicators before and during pregnancy, and form an early warning system for the effects of maternal endocrine and metabolic diseases on the metabolism of offspring. It will not only help to warn the impact of maternal endocrine system and metabolic diseases on the metabolism of offspring, but also build a transformation platform for the study of maternal endocrine and metabolic diseases and metabolic health of offspring, which has important clinical value for curbing the rapid growth of metabolic diseases such as diabetes and obesity in China. It is expected to provide an important theoretical basis for the window period of prevention and treatment of endocrine and metabolic diseases in China.
Detailed description
Due to the rapid changes in the environment and lifestyle, women of childbearing age often suffer from endocrine and metabolic diseases such as diabetes and thyroid diseases, resulting in poor intrauterine development environment in the early life. Maternal endocrine metabolic diseases and nutritional status not only affect their own health, but also greatly affect the metabolic health of their offspring. Hyperglycemia and thyroid dysfunction during pregnancy can increase the risk of obesity, metabolic syndrome and diabetes in offspring. The developmental origin of health and disease (DOHaD) is a well-known theory about the effect of early developmental environment (fetus and newborn) on the metabolic health of offspring. Several well-known international birth cohorts have confirmed that maternal malnutrition during pregnancy can lead to an increased risk of metabolic diseases in adult offspring. Previously, Xiao 's team found that low birth weight was an independent risk factor for abnormal glucose and lipid metabolism in adulthood through the 'Concord birth-old age' cohort study, which confirmed the DOHaD theory for the first time in the Chinese population. The above retrospective cohort study provides epidemiological evidence for the DOHaD theory. However, due to its early start and the lack of a comprehensive database of clinical data and biological samples at different stages of the subjects' lives, it is difficult to deeply analyze the high-risk factors of metabolic abnormalities in offspring, and it is difficult to effectively intervene and block the 'origin of metabolic diseases' from the early stage of life development. In addition, cross-generational studies at home and abroad are mostly retrospective and cross-sectional studies, with selection bias and information bias. Prospective birth cohort studies covering the whole life cycle of maternal endocrine and metabolic diseases are urgently needed. This project will continue to focus on the endocrine system and metabolic diseases of women of childbearing age in this large birth cohort, and cooperate with the Department of Endocrinology, Obstetrics, Pediatrics and Nutrition of Peking Union Medical College Hospital to construct a large-scale prospective cohort of maternal endocrine and metabolic diseases in the whole pregnancy cycle, establish a clinical database and a long-term follow-up bio-bank, and form an early predictive system for the impact of maternal endocrine and metabolic diseases on the metabolism of offspring, so as to provide a scientific basis for comprehensively predicting the short-term and long-term metabolic trajectories of offspring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease group | – | –No interventions |
| Control group | – | –No interventions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with metabolic disease before or during pregnancy and control group
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Twin or multiple pregnancy
- Severe pregnancy complications
- Complicated with important heart, liver, kidney, blood system and autoimmune diseases before pregnancy
- Associated with other diseases that may affect intestinal flora or metabolomics, including inflammatory bowel disease, irritable bowel syndrome, celiac disease, etc.
- Gastrointestinal and biliary surgeries, including bariatric surgery and cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational diabetes mellitus
Time frame: Measure blood glucose up to 28 weeks of pregnancy
Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy
Thyroid dysfunction during pregnancy
Time frame: Measure thyroid function up to 28 weeks of pregnancy
Slightly higher TSH or positive TPOAb; 140 participants with thyroid dysfunction during pregnancy
Abnormal metabolism of offspring
Time frame: 1 year
Abnormal birth weight，blood sugar etc; 300 participants
Diabetes mellitus complicating pregnancy
Time frame: Measure blood glucose up to 28 weeks of pregnancy
Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 34879977Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.
- Background: PubMed 10852853Osmond C, Barker DJ. Fetal, infant, and childhood growth are predictors of coronary heart disease, diabetes, and hypertension in adult men and women. Environ Health Perspect. 2000 Jun;108 Suppl 3(Suppl 3):545-53. doi: 10.1289/ehp.00108s3545.
- Background: PubMed 18070988Xiao X, Zhang ZX, Cohen HJ, Wang H, Li W, Wang T, Xu T, Liu A, Gai MY, Ying S, Schmitz O, Yi Z. Evidence of a relationship between infant birth weight and later diabetes and impaired glucose regulation in a Chinese population. Diabetes Care. 2008 Mar;31(3):483-7. doi: 10.2337/dc07-1130. Epub 2007 Dec 10.
- Background: PubMed 29728364Rawal S, Olsen SF, Grunnet LG, Ma RC, Hinkle SN, Granstrom C, Wu J, Yeung E, Mills JL, Zhu Y, Bao W, Ley SH, Hu FB, Damm P, Vaag A, Tsai MY, Zhang C. Gestational Diabetes Mellitus and Renal Function: A Prospective Study With 9- to 16-Year Follow-up After Pregnancy. Diabetes Care. 2018 Jul;41(7):1378-1384. doi: 10.2337/dc17-2629. Epub 2018 May 4.
- Background: PubMed 28070760Kooijman MN, Kruithof CJ, van Duijn CM, Duijts L, Franco OH, van IJzendoorn MH, de Jongste JC, Klaver CC, van der Lugt A, Mackenbach JP, Moll HA, Peeters RP, Raat H, Rings EH, Rivadeneira F, van der Schroeff MP, Steegers EA, Tiemeier H, Uitterlinden AG, Verhulst FC, Wolvius E, Felix JF, Jaddoe VW. The Generation R Study: design and cohort update 2017. Eur J Epidemiol. 2016 Dec;31(12):1243-1264. doi: 10.1007/s10654-016-0224-9. Epub 2017 Jan 9.
- Background: PubMed 34327418Lv H, Diao F, Du J, Chen T, Meng Q, Ling X, Li H, Song C, Xi Q, Jiang Y, Xu Y, Tao S, Huang L, Wen M, Peng M, Liu C, Lu Q, He Y, Yin Y, Liu X, Xu B, Han X, Zhou K, Jiang T, Zhao Y, Ma H, Jin G, Xia Y, Liu J, Lin Y, Hu Z, Shen H. Assisted reproductive technology and birth defects in a Chinese birth cohort study. Lancet Reg Health West Pac. 2021 Jan 22;7:100090. doi: 10.1016/j.lanwpc.2020.100090. eCollection 2021 Feb.
- Background: PubMed 32585501Wang YY, Li Q, Guo Y, Zhou H, Wang QM, Shen HP, Zhang YP, Yan DH, Li S, Chen G, Zhou S, He Y, Yang Y, Peng ZQ, Wang HJ, Ma X. Ambient temperature and the risk of preterm birth: A national birth cohort study in the mainland China. Environ Int. 2020 Sep;142:105851. doi: 10.1016/j.envint.2020.105851. Epub 2020 Jun 22.
- Background: PubMed 35299765Zhou L, Li S, Zhang Q, Yu M, Xiao X. Maternal Exercise Programs Glucose and Lipid Metabolism and Modulates Hepatic miRNAs in Adult Male Offspring. Front Nutr. 2022 Mar 1;9:853197. doi: 10.3389/fnut.2022.853197. eCollection 2022.
- Background: PubMed 35479641Liu J, Ding L, Zhai X, Wang D, Xiao C, Hui X, Sun T, Yu M, Zhang Q, Li M, Xiao X. Maternal Dietary Betaine Prevents High-Fat Diet-Induced Metabolic Disorders and Gut Microbiota Alterations in Mouse Dams and Offspring From Young to Adult. Front Microbiol. 2022 Apr 5;13:809642. doi: 10.3389/fmicb.2022.809642. eCollection 2022.
- Background: PubMed 28320771Zhang Q, Sun X, Xiao X, Zheng J, Li M, Yu M, Ping F, Wang Z, Qi C, Wang T, Wang X. The effect of maternal chromium status on lipid metabolism in female elderly mice offspring and involved molecular mechanism. Biosci Rep. 2017 Apr 28;37(2):BSR20160362. doi: 10.1042/BSR20160362. Print 2017 Apr 30.
- Background: PubMed 32626663Zhou L, Xiao X, Li M, Zhang Q, Yu M, Zheng J, Deng M. Maternal Exercise Improves High-Fat Diet-Induced Metabolic Abnormalities and Gut Microbiota Profiles in Mouse Dams and Offspring. Front Cell Infect Microbiol. 2020 Jun 17;10:292. doi: 10.3389/fcimb.2020.00292. eCollection 2020.
- Derived from this study: PubMed 41455930Zeng Y, Yu J, Ren Y, Ren J, Chen H, Zhang Q, Xiao X. Maternal Endocrine and Metabolic Health and Outcomes (MEMO): a prospective cohort study of gestational diabetes mellitus and subclinical hypothyroidism in China. BMC Pregnancy Childbirth. 2025 Dec 27;26(1):147. doi: 10.1186/s12884-025-08294-5.
- Individual participant dataSharing planned: No
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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.
Xinhua Xiao study director
Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Dysfunction and Diabetes Mellitus, 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 0 inclusion and 7 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 24 Nov 2023. 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 Xinhua Xiao (+86-10-139 1183 0085, xiaoxh2014@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes mellitus (time frame: Measure blood glucose up to 28 weeks of pregnancy). The study lists 4 primary outcomes in all. 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 NCT05952739, which also lists 12 linked publications.
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 24 Nov 2023.