NCT07806695 · Mayo Clinic
Islet Function in Gestational Diabetes
What this study is about
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
View original scientific description
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
Interventions
DRUG
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations