A Study Using Breath Tests to Identify Patients at Risk for Gestational Diabetes

NCT07347262 | Completed

• 1 other identifier: 0116-19-KMC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• The aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.

  We will assess feasibility via recruitment and test completion.

  At the time of the glucose tolerance test (GCT/ OGTT)

• To evaluate the diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.

  We will assess agreement between exogenous glucose oxidation (breath test) and blood glucose (OGTT).

  At the time of the glucose tolerance test (GCT/ OGTT)

Interventions

Noninvasive Breath Test in Order to Identify Patients at Risk for Developing Gestational Diabetes DIAGNOSTIC_TEST

After a short explanation on how to use the kit participants will be asked to sample their breath every 15 minutes starting 30 minutes before the ingestion of glucose and ending six hours after the ingestion.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.

You may qualify if:

• Pregnant women
• ages 18 to 45 years old
• A singleton pregnancy
• Confirmed gestational age by a documented first-trimester ultrasound.

You may not qualify if:

• Patients below the age of 18 or above 45 years-old
• Patients diagnosed with gestational or pre-gestational diabetes
• Patients with multiple pregnancies or fetuses with congenital and/or chromosomal anomalies
• Patients after a multifetal pregnancy reduction (spontaneous or iatrogenic)
• Patients not having a sonographic dating during the first trimester of pregnancy
• Patients with conditions or medications that affect glucose metabolism
• Patients who will refuse to consent, or are not fit or able to read, understand, or sign an informed consent.

Sponsors & Collaborators

• Kaplan Medical Center: lead
• University of Galway: collaborator

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

Location

Related Publications (23)

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• Roeckner JT, Sanchez-Ramos L, Jijon-Knupp R, Kaunitz AM. Single abnormal value on 3-hour oral glucose tolerance test during pregnancy is associated with adverse maternal and neonatal outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016 Sep;215(3):287-97. doi: 10.1016/j.ajog.2016.04.040. Epub 2016 Apr 29.

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• Dillon EL, Janghorbani M, Angel JA, Casperson SL, Grady JJ, Urban RJ, Volpi E, Sheffield-Moore M. Novel noninvasive breath test method for screening individuals at risk for diabetes. Diabetes Care. 2009 Mar;32(3):430-5. doi: 10.2337/dc08-1578. Epub 2008 Dec 15.

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• Morey S, Shafat A, Clegg ME. Oral versus intubated feeding and the effect on glycaemic and insulinaemic responses, gastric emptying and satiety. Appetite. 2016 Jan 1;96:598-603. doi: 10.1016/j.appet.2015.11.002. Epub 2015 Nov 10.

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• Sevket O, Ates S, Uysal O, Molla T, Dansuk R, Kelekci S. To evaluate the prevalence and clinical outcomes using a one-step method versus a two-step method to screen gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2014 Jan;27(1):36-41. doi: 10.3109/14767058.2013.799656. Epub 2013 May 30.

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• Olagbuji BN, Aderoba AK, Kayode OO, Awe CO, Akintan AL, Olagbuji YW; Gestational Diabetes Study Group-Nigeria. Accuracy of 50-g glucose challenge test to detect International Association of Diabetes and Pregnancy Study Groups criteria-defined hyperglycemia. Int J Gynaecol Obstet. 2017 Dec;139(3):312-317. doi: 10.1002/ijgo.12304. Epub 2017 Sep 14.

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• Arbib N, Gabbay-Benziv R, Aviram A, Sneh-Arbib O, Wiznitzer A, Hod M, Chen R, Hadar E. Third trimester abnormal oral glucose tolerance test and adverse perinatal outcome. J Matern Fetal Neonatal Med. 2017 Apr;30(8):917-921. doi: 10.1080/14767058.2016.1190825. Epub 2016 Jun 8.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath samples

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: January 16, 2026
• Study Start: December 18, 2020
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

IL (1)