Blood sugar control and a GLP-1 medicine's effect on islet GLP-1 in people with type 1 or type 2 diabetes
The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People
We will test whether tighter blood sugar control and a GLP-1 drug (liraglutide) change islet GLP-1 in people with type 1 or type 2 diabetes who use insulin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06976619 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study will compare the effects of improved glycemic control with or without a GLP-1 receptor agonist (liraglutide) on islet GLP-1 production in people with insulin-treated type 1 and type 2 diabetes. Participants will receive liraglutide injections or saline while glycemic control is managed, and investigators will measure islet-related GLP-1 signals and related insulin and glucagon responses. The design tests whether presence or absence of functional beta cells (T2DM vs T1DM) changes the islet response to GLP-1 agonism. All procedures and visits are conducted at a single center with laboratory and metabolic assessments to characterize paracrine islet effects.
Who should consider this trial
Good fit: Adults aged 25–70 with type 1 or type 2 diabetes who are treated with insulin, have HbA1c ≤10%, no major abdominal surgery history, and no GLP-1 receptor agonist use in the past year are ideal candidates.
Not a fit: People who are younger than 25 or older than 70, pregnant, have active systemic illness or malignancy, symptomatic macro- or microvascular disease, or recent GLP-1 use are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could identify ways to modulate islet hormone signaling that may improve insulin and glucagon regulation and inform new treatments for diabetes.
How similar studies have performed: Related animal and human studies have shown islet GLP-1 signaling and effects of GLP1R blockade, but using GLP-1 agonists to differentially target islet GLP-1 in T1 versus T2 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 or type 2 diabetes treated with insulin Exclusion Criteria: 1. Age \< 25 or \> 70 years. 2. HbA1c \> 10.0% 3. For female subjects: positive pregnancy test at the time of enrollment or study 4. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. 5. Prior use of GLP-1 receptor agonists in the previous year. 6. Active systemic illness or malignancy. 7. Symptomatic macrovascular or microvascular disease.
Where this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.