How pancreatic (islet) GLP-1 affects blood sugar in prediabetes
Official title: The Role of Islet GLP-1 in the Pathogenesis of Prediabetes
Run by Mayo Clinic · NCT06967558 · Data updated 2026-11-12
We will test whether blocking the GLP-1 receptor changes insulin and glucagon release and fasting glucose in people with prediabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | October 30, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT06967558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 25–70 with prediabetes (impaired fasting glucose or impaired glucose tolerance), stable weight, fasting glucose under 126 mg/dL, 2-hour OGTT under 200 mg/dL, and not taking glucose-lowering medications are ideal candidates.
✕Probably not a fit
People with established type 2 diabetes, those taking glucose-lowering drugs, those outside the 25–70 age range, or with active systemic illness or prior qualifying upper abdominal surgery are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial uses a GLP-1 receptor blocker (exendin 9-39) versus saline to probe the role of endogenous islet GLP-1 in people with impaired fasting glucose or impaired glucose tolerance. Participants undergo metabolic testing including a 75 g oral glucose tolerance test and measures of islet hormone responses to determine effects on fasting glucose and alpha- and beta-cell function. The protocol enrolls adults 25–70 years old with prediabetes, stable weight, and no use of glucose-lowering drugs, and excludes those with prior major upper abdominal surgery, active illness or symptomatic vascular disease. All study procedures are performed at the Mayo Clinic in Rochester, Minnesota.
Why it matters
Potential benefit: If successful, the results could identify whether intra-islet GLP-1 helps maintain normal insulin and glucagon responses and point to new prevention strategies for progression to type 2 diabetes.
How similar studies have gone: Previous human and animal studies have shown that GLP-1 receptor blockade alters islet function—effects that were pronounced in early type 2 diabetes—but the role of this mechanism in prediabetes remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * People with stable weight and no history of diabetes. * Fasting glucose \< 126 mg/dL * 2hr glucose after 75g OGTT \< 200 mg/dL Exclusion Criteria: * 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.
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Adrian Vella, MD — Mayo Clinic
- Study coordinator: Adrian Vella, MD
- Email: vella.adrian@mayo.edu
- Phone: 507-255-6515
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.