ClinicalTrials.gg
RecruitingNCT07806695Updated Sep 8, 2026

Islet Function in Gestational Diabetes

A Phase 1 interventional study of Exendin 9-39 in Gestational Diabetes Mellitus, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 251 studies in Diabetes, Gestational with a site in United States — 53 open to participants now, 65 under way, 2 of them phase 3. Diabetes, Gestational · United States.

Planned enrollment
88th of 194
90 · median 80
Started
2026
with 10 others
Phase 1
11 of 251
5 open now
Primary completion
2030-03
later than 60 of 64 live
Registered
250th of 251
by date

Among the 251 studies in Diabetes, Gestational with a site in United States, this one is the 88th largest by planned enrollment of the 194 interventional ones that give a count, is one of 11 that started in 2026, is one of 11 in phase 1, reaches primary completion later than 60 of the 64 other live ones, and was the 250th registered.

Diabetes, Gestational

877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.

Browse Diabetes, Gestational studies →

Open to participants now

53 of the 251 studies in Diabetes, Gestational with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.

This study: 20 Years to 40 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 251 studies in Diabetes, Gestational with a site in United States, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Gestational Diabetes Mellitus

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04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and complete planned pregnancy and postpartum study visits.

Exclusion criteria

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 ≥ 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)
  • \< than 11 g/dL
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Women With Gestational Diabetes Mellitus

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

    Drug: Exendin 9-39

  • 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.

    Drug: Exendin 9-39

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. G50

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

    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.

Secondary outcomes

  1. Glucagon Secretion Rate

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

    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.

  2. 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.

    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.

  3. 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.

    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.

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
    • Jeanette Laugen · Contact507-255-8110
    • Amy Zipse · Contact507-255-9278
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Mar 2030, 42 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 8, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2030
CompletionEst.
Dec 2030
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07806695
Lead sponsor
Mayo Clinic
Responsible party
Aoife Egan (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 8, 2026

Study contacts

Jeanette Laugen
Contact
laugen.jeanette@mayo.edu
507-255-8110
Amy Zipse
Contact
zipse.amy@mayo.edu
507-255-9278
Aoife Egan, MB, BCh, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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