Can a hormone blocking drug reveal why gestational diabetes happens?

NCT ID NCT07806695

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Recruitment status, easiest to join first

Recruiting now This study
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By invitation only
Not open to general applications. Only people the study team invites can take part.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Approved
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First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers at Mayo Clinic are studying how the pancreas changes during and after pregnancy in women with gestational diabetes. The trial involves pregnant women who have completed their second-trimester screening and are classified as having gestational diabetes or not. After delivery, participants receive an infusion of exendin 9-39, a drug that blocks a hormone involved in blood sugar control, to measure how the pancreas responds to glucose. The goal is to understand the underlying function of insulin- and glucagon-producing cells, which may help explain the development of gestational diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Exendin 9-39, given as an intravenous infusion during one postpartum study visit
What this could lead to
If this trial succeeds, it could clarify how the pancreas adapts in pregnancy and why some women develop gestational diabetes, pointing toward better screening or prevention strategies.
What could go wrong
This is an early-phase study focused on measuring hormone responses, not on treating the condition. Results may not directly change clinical care, and the drug infusion may cause side effects.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  2. The official record

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Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

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