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The Role of Islet GLP-1 in the Pathogenesis of Prediabetes Phase 2 60

Recruiting
Clinical Trial NCT06967558 is designed to study Basic Science for PreDiabetes. It is a Phase 2 interventional study that is recruiting, having started on November 1, 2025, with plans to enroll 60 participants. Led by Mayo Clinic, it is expected to complete by March 31, 2028. The latest data from ClinicalTrials.gov was last updated on December 15, 2025.
Brief Summary
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...Show More
Detailed Description
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. This supports other evidence (rodents and humans) that through the (inducible) expression of a prohormone convertase (PC-1/3), the α-cell can process proglucagon to intact GLP-1. 'Islet' or 'pancreatic' GLP-1 acts in a paracrine fashion to regulate ins...Show More
Official Title

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

Conditions
PreDiabetes
Other Study IDs
  • 24-007677
NCT ID Number
NCT06967558
Start Date (Actual)
2025-11-01
Last Update Posted
2025-12-15
Completion Date (Estimated)
2028-03-31
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Impaired Fasting Glucose
Impaired Glucose Tolerance
GLP-1
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorExendin 9-39
Subjects will receive exendin 9-39 during the study
Exendin 9-39
Exendin 9-39 is a competitive antagonist of the GLP-1 receptor
Placebo ComparatorSaline
Subjects will receive saline during the study
Saline
Saline
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Alpha-cell responsivity to glucose as measured by G50
The change in glucose necessary to suppress glucagon secretion by 50%
0-240 minutes
Beta-cell responsivity to glucose
This is measured as the gradient of the increase in insulin secretion rate per unit increase in glucose concentration
0-240 minutes
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • People with stable weight and no history of diabetes.
  • Fasting glucose < 126 mg/dL
  • 2hr glucose after 75g OGTT < 200 mg/dL

  • Age < 25 or > 70 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
  • HbA1c > 6.5%
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
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Study Responsible Party
Adrian Vella, Principal Investigator, Professor of Medicine, Mayo Clinic
Study Central Contact
Contact: Adrian Vella, MD, 507-255-6515, [email protected]
1 Study Locations in 1 Countries

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Amy O'Byrne, Contact, 507-255-8547, [email protected]
Adrian Vella, Principal Investigator
Recruiting