Recruiting
Phase 1

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07806695

Conditions

Gestational Diabetes Mellitus

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Not accepted

Interventions

Exendin 9-39

Study Details

Brief summary:

The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.

Conditions

Gestational Diabetes Mellitus

Study ID

NCT07806695

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Women With Gestational Diabetes Mellitus

Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.

experimental: Women Without Gestational Diabetes Mellitus

Pregnant participants without gestational diabetes mellitus, matched to the gestational diabetes group by parity, age, ethnicity, gestational week at diagnosis comparator timepoint, and first trimester body mass index.

Interventions

Exendin 9-39

Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol/kg/min for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period

Primary outcome measure

  • G50 [ Time Frame: During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery. ]

Central Contacts and Locations

Central contacts

Jeanette Laugen

507-255-8110laugen.jeanette@mayo.edu

Amy Zipse

507-255-9278zipse.amy@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jeanette Laugen

507-255-8110

Amy Zipse

507-255-9278

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-08.