Islet function in gestational diabetes: see if pancreas changes during and after pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial explores how pancreatic function may change during and after pregnancy in individuals with gestational diabetes or those without it. The study administers Exendin 9-39 to assess its effects on islet activity. Eligible participants include pregnant individuals with viable singleton pregnancies past mid-pregnancy who have or have not gestational diabetes, and who can provide informed consent and attend all visits. Exclusion criteria include active systemic illness, pre-pregnancy diabetes, multiple gestations, major fetal anomalies, and several glucose-related thresholds. The Mayo Clinic leads the study with collaboration from NIDDK, and recruitment is centered at Mayo Clinic in Rochester, MN.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant individuals with a viable singleton pregnancy who have completed second trimester gestational diabetes screening and are eligible for classification as either gestational diabetes mellitus or no gestational diabetes mellitus.
* Participants must be willing and able to provide informed consent and complete planned pregnancy and postpartum study visits.

Exclusion Criteria:

* Active systemic illness (e.g. chronic kidney disease, hypertension)
* Pre-pregnancy diabetes mellitus
* Multiple gestation, major fetal anomaly, or non-viable pregnancy on ultrasound
* Fasting glucose ≥ 100 mg/dL or HbA1c ≥ 5.7% in early pregnancy
* One abnormal value on the 3-hour 100 g oral glucose tolerance test
* Glucose at least 190 mg/dL on glucose challenge testing without subsequent 3-hour oral glucose tolerance testing
* Use of medication affecting glucose metabolism before pregnancy or in early pregnancy
* Use of glucose-lowering medication (e.g. metformin, glyburide) other than insulin to treat gestational diabetes mellitus in the current pregnancy
* History of upper gastrointestinal surgery that alters gastric emptying (e.g. bariatric surgery)
* Hemoglobin \< than 11 g/dL

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Aoife Egan, MB, BCh, PhD — Mayo Clinic
• Study coordinator: Jeanette Laugen
• Email: laugen.jeanette@mayo.edu
• Phone: 507-255-8110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Managing cardiometabolic risk in women with gestational diabetes using continuous glucose monitoring and mobile health

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• Comparing Metformin and Insulin for Gestational Diabetes Treatment

  This study is testing whether metformin is as effective as insulin for treating gestational diabetes in pregnant people and looks at how safe both treatments are for mothers and their babies.

  Recruiting at 22 sites Phase 4 Ohio State University · Tuscaloosa, Alabama and 25 other locations · NCT06445946

• Continuous glucose monitoring for pregnant women with gestational diabetes to improve mother and baby outcomes

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  Recruiting National Taiwan University Hospital · Hsinchu · NCT06436326

• Investigating how meal timing affects blood sugar during pregnancy

  This study is testing how the timing of meals affects blood sugar levels in pregnant women at risk for gestational diabetes to see if it can help manage their health better.

  Recruiting National Taiwan University Hospital · Taipei, Zhongzheng District · NCT06215352

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.