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

NCT07517406 | Recruiting

• 1 other identifier: 2026-37
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  Between 24 and 28 weeks of gestation

Secondary Outcomes (1)

• Polyhydramnios

  Between 24 and 40 weeks of gestation

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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, HbA1c, urine glucose, and/or OGTT results if tolerated)

You may not qualify if:

• 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

Sponsors & Collaborators

• Burak Deniz Aydoğdu: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Glucose Intolerance

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Burak Deniz AYDOĞDU, MD

  Prof. Dr. Cemil Taşcıoğlu City Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Deniz AYDOĞDU, MD

CONTACT

90 539-618-22-28; burakd.1992@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: April 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)