ClinicalTrials.gg
RecruitingNCT07517406BARI-GDMUpdated Apr 8, 2026

Glycemic Markers for Predicting Gestational Diabetes in Pregnant Women With Previous Bariatric Surgery

An observational study in Gestational Diabetes Mellitus (GDM), Pregnancy Complications and History of Bariatric Surgery, sponsored by Burak Deniz Aydoğdu. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Burak Deniz Aydoğdu · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Diabetes, Gestational with a site in Turkey — 9 open to participants now, 12 under way, none of them phase 3. Diabetes, Gestational · Turkey.

Planned enrollment
15th of 24
84 · median 100
Started
2026
with 2 others
Observational
24 of 52
4 open now
Primary completion
2027-12
later than 10 of 11 live
Registered
46th of 52
by date

Among the 52 studies in Diabetes, Gestational with a site in Turkey, this one is the 15th largest by planned enrollment of the 24 observational ones that give a count, is one of 3 that started in 2026, is one of 24 observational ones, reaches primary completion later than 10 of the 11 other live ones, and was the 46th registered.

Diabetes, Gestational

877 studies on the registry are indexed under Diabetes, Gestational; 200 are open to participants now.

Browse Diabetes, Gestational studies →

Open to participants now

9 of the 52 studies in Diabetes, Gestational with a site in Turkey are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 136 Diabetes, Gestational studies recruiting now, 62 (46%) set no upper age limit and 72 (53%) stop at 75 or younger; 13 take children under 18; 62 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

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02

Study summary

Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population.

The aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery.

Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models.

This study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.

Read the detailed description

Gestational diabetes mellitus (GDM) is a common pregnancy complication associated with increased risks of maternal and perinatal morbidity. Early identification and appropriate management are essential to reduce adverse outcomes such as macrosomia, polyhydramnios, and cesarean delivery.

The standard diagnostic approach for GDM is the 75-gram oral glucose tolerance test (OGTT). However, women with prior bariatric surgery frequently experience intolerance to glucose loading due to dumping syndrome, which limits the reliability and feasibility of OGTT in this population. Consequently, alternative diagnostic strategies are required.

This prospective observational cohort study will be conducted at Prof. Dr. Cemil Taşcıoğlu City Hospital between February 2026 and December 2027. Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled during the first or second trimester. Participants will be categorized according to OGTT tolerance (tolerated vs. not tolerated/refused).

Baseline demographic characteristics including maternal age, gravidity, parity, obstetric history, and educational status will be recorded. Glycemic parameters assessed during routine antenatal follow-up will include fasting plasma glucose, postprandial glucose, HbA1c levels, and urinary glucose measurements. Second and third trimester ultrasound findings will be documented. Pregnancy outcomes including diagnosis of GDM, macrosomia (birth weight >4000 g), and polyhydramnios will be recorded.

The primary objective is to evaluate the predictive value of routine glycemic markers for GDM. Secondary objectives include assessing their association with macrosomia and polyhydramnios.

Statistical analyses will be performed using SPSS version 27. Continuous variables will be summarized as mean ± standard deviation or median (interquartile range) depending on distribution. Comparisons between groups will be performed using the Mann-Whitney U test. Multivariable logistic regression models will be used to determine independent predictors of GDM and other pregnancy complications after adjustment for potential confounders.

This study aims to provide evidence for alternative screening approaches in pregnant women with prior bariatric surgery who are unable to tolerate OGTT and to improve clinical decision-making in this growing patient population.

03

Conditions studied

  • Gestational Diabetes Mellitus (GDM)
  • Pregnancy Complications
  • History of Bariatric Surgery

Keywords

  • Gestational Diabetes Mellitus
  • Bariatric Surgery
  • Glucose Intolerance
  • Glycemic Markers
  • Oral Glucose Tolerance Test
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of pregnant women aged 18-50 years with a history of bariatric surgery prior to conception who were followed at the Department of Obstetrics and Gynecology of Prof. Dr. Cemil Taşcıoğlu City Hospital. Eligible participants have documented glycemic parameters during the first and/or second trimester (including fasting plasma glucose, HbA1c, urine glucose and/or oral glucose tolerance test results) and available third trimester and/or delivery records. Only singleton pregnancies with complete clinical data are included.

Eligibility criteria

Inclusion Criteria

  • Pregnant women aged 18-50 years
  • Singleton pregnancy
  • History of bariatric surgery prior to pregnancy
  • Followed at Prof. Dr. Cemil Taşcıoğlu City Hospital, Department of Obstetrics and Gynecology
  • Availability of glycemic parameters during early pregnancy (≤14 weeks) and/or between 24 and 28 weeks of gestation (fasting plasma glucose, , urine glucose, and/or OGTT results if tolerated)
  • Availability of sonographic and clinical follow-up data between 28 weeks of gestation and delivery (up to 40 weeks) Exclusion Criteria
  • Age \<18 years or >50 years
  • Multiple pregnancy
  • Presence of known chronic systemic disease (e.g., pregestational diabetes or endocrine disorders)
  • Incomplete or missing clinical data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (estimated)
Target follow-up
9 Months
Patient registry
Yes

Groups and cohorts

  • OGTT Tolerant Group

    Pregnant women with a history of bariatric surgery who tolerate and complete the 75-gram oral glucose tolerance test during pregnancy.

  • OGTT Non-Tolerant Group

    Pregnant women with a history of bariatric surgery who are unable to tolerate or refuse the 75-gram oral glucose tolerance test during pregnancy.

06

What researchers measure

Primary outcomes

  1. Development of Gestational Diabetes Mellitus (GDM)

    Diagnosis of gestational diabetes mellitus based on standard 75-gram oral glucose tolerance test (OGTT) criteria or clinical diagnostic criteria in women unable to tolerate OGTT.

    Time frame: Between 24 and 28 weeks of gestation

Secondary outcomes

  1. Polyhydramnios

    Polyhydramnios diagnosed by ultrasound during pregnancy as documented in routine antenatal follow-up.

    Time frame: Between 24 and 40 weeks of gestation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to institutional policies and national data protection regulations. Although this is a prospective study, the informed consent obtained from participants does not include permission for public data sharing. All collected data will be analyzed in de-identified form and handled in accordance with ethical approval and applicable data protection laws.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.

Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's planned 22 months is below that.

Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2026
First posted
Apr 8, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07517406
Lead sponsor
Burak Deniz Aydoğdu
Responsible party
Burak Deniz Aydoğdu (Specialist in Obstetrics and Gynecology, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Sponsor-investigator
First posted
Apr 8, 2026
Start date
Feb 1, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 8, 2026

Study contacts

Burak Deniz AYDOĞDU, MD
Contact
burakd.1992@hotmail.com
90 539-618-22-28
Burak Deniz AYDOĞDU, MD
principal investigator · Prof. Dr. Cemil Taşcıoğlu City Hospital, Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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