Islet Function in Gestational Diabetes

NCT07806695 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 26-0077031R01DK148528-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• G50

  The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function.

  During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

Secondary Outcomes (3)

• Glucagon Secretion Rate

  During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

• delta insulin secretion rate/delta glucose

  During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

• β-Cell responsivity (Φ)

  During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

Study Arms (2)

Women With Gestational Diabetes Mellitus

EXPERIMENTAL

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

Drug: Exendin 9-39

Women Without Gestational Diabetes Mellitus

EXPERIMENTAL

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.

Drug: Exendin 9-39

Interventions

Exendin 9-39 DRUG

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

Women With Gestational Diabetes Mellitus; Women Without Gestational Diabetes Mellitus

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

exendin (9-39)

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 Officials

• Aoife Egan, MB, BCh, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Laugen

CONTACT

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

Amy Zipse

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)