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Recruiting

NCT Number: NCT07806695

Islet Function in Gestational Diabetes

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

Recruiting

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Amy Zipse

CONTACT

507-255-9278

Jeanette Laugen

CONTACT

507-255-8110

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Glucagon Secretion Rate

    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.

    The amount of glucagon produced over time expressed as pmol/min. A measurement of α-cell function.

  2. delta insulin secretion rate/delta glucose

    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.

    This measurement quantifies the change in insulin secretion in response to rising glucose concentrations. it is a surrogate of β-cell function. Insulin secretion rate will be calculated from C-peptide concentrations using nonparametric deconvolution and population-based measures of C-peptide kinetics.

  3. β-Cell responsivity (Φ)

    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.

    This index quantifies the relationship between fasting glucose and fasting insulin secretion rate. This will allow us to assess and quantify fasting β-cell function.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Zipse

CONTACT

[email protected]

507-255-9278

Jeanette Laugen

CONTACT

[email protected]

507-255-8110

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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