The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People With Type 1 and Type 2 Diabetes
NCT ID: NCT06976619
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-10-03
2029-03-31
Brief Summary
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Detailed Description
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There is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell. β-cell secretion of the signaling peptide 14-3-3-Zeta is decreased by GLP1R agonism (Fig.1), stimulating α-cell production of GLP-1. This is a testable hypothesis in humans; people with type 1 diabetes (T1DM) have dysregulated glucagon secretion and evidence of islet GLP-1. It is unclear if the effects of GLP1R agonism on islet GLP-1 differ compared to T2DM. This experiment will examine the effect of glycemic control ± a GLP1R agonist on islet GLP-1 in people with (T2DM) and without (T1DM) β-cells.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Type 1 diabetes - Placebo arm
Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase
Saline Injections
Saline in syringes to serve as placebo for single blind study
Type 1 diabetes - Liraglutide arm
Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase
Liraglutide Pen Injector
Liraglutide 0.6mg
Type 2 diabetes - Placebo arm
Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase
Saline Injections
Saline in syringes to serve as placebo for single blind study
Type 2 diabetes - Liraglutide arm
Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase
Liraglutide Pen Injector
Liraglutide 0.6mg
Interventions
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Liraglutide Pen Injector
Liraglutide 0.6mg
Saline Injections
Saline in syringes to serve as placebo for single blind study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
25 Years
70 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Adrian Vella
Professor of Medicine
Principal Investigators
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Adrian Vella, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-007682
Identifier Type: -
Identifier Source: org_study_id
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