Gestational Diabetes MellitusPhase 1NCT07806695
Islet Function in Gestational Diabetes
A Phase 1 study testing Exendin 9-39 in people with Gestational Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Exendin 9-39
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jeanette Laugen, 507-255-8110
Amy Zipse, 507-255-9278
About this study
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Exendin 9-39
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin 9-39Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Women With Gestational Diabetes Mellitus | Experimental | Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits. Receives: 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. Receives: Drug: Exendin 9-39 |
What is being measured
The primary outcome is the main question the study is designed to answer.
G50
The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function.
Measured: 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
The amount of glucagon produced over time expressed as pmol/min. A measurement of α-cell function.
Measured: 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
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.
Measured: 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)
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.
Measured: During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aoife Egan, Mayo Clinic
- Investigators
- Aoife Egan, MB, BCh, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806695
- Sponsor's protocol ID
- 26-007703
- Other IDs
- 1R01DK148528-01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Function in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07806695
- Acronym / sponsor ID
- 26-007703
- Conditions
- Gestational Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women With Gestational Diabetes Mellitus | Experimental | Drug: Exendin 9-39Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits. |
| Women Without Gestational Diabetes Mellitus | Experimental | Drug: Exendin 9-39Pregnant 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exendin 9-39Exendin 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 | Drug | Women With Gestational Diabetes Mellitus, Women Without Gestational Diabetes Mellitus |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aoife Egan, MB, BCh, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exendin 9-39 in people with Gestational Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette Laugen (507-255-8110, laugen.jeanette@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.