The Role of Islet GLP-1 in the Pathogenesis of Prediabetes

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06967558
Phase
PHASE2
Status
Recruiting

Conditions

  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Exendin 9-39 — BIOLOGICAL
    Exendin 9-39 is a competitive antagonist of the GLP-1 receptor
  • Saline — BIOLOGICAL
    Saline

Study Details

We recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1/3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. At present it is unknown if these abnormalities develop in prediabetes and whether they contribute to the phenotypes observed. In this experiment we will use blockade of GLP1R to probe the contribution of endogenous GLP-1 secretion to the regulation of fasting glucose and islet function in prediabetes.

Key Dates

Start date
Nov 1, 2025
Status verified
Dec 2025
Primary completion
Oct 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Exendin 9-39
    Subjects will receive exendin 9-39 during the study
  • Placebo Comparator: Saline
    Subjects will receive saline during the study

Primary Outcome Measure

Alpha-cell responsivity to glucose as measured by G50 [ Time Frame: 0-240 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Amy O'Byrne
507-255-8547
Adrian Vella (PRINCIPAL_INVESTIGATOR)

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