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The Effect of rs7903146 Genotype on Islet GLP-1 Production in Humans Phase 2 80

Not yet recruiting
Clinical Trial NCT06972407 is designed to study Basic Science for Genetic Predisposition, Type2diabetes. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on October 1, 2026 until the study accrues 80 participants. Led by Mayo Clinic, this study is expected to complete by March 1, 2029. The latest data from ClinicalTrials.gov was last updated on January 30, 2026.
Brief Summary
The investigators 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. Common genetic var...Show More
Detailed Description
The investigators 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 ...Show More
Official Title

The Effect of rs7903146 Genotype on Islet GLP-1 Production in Humans

Conditions
Genetic PredispositionType2diabetes
Other Study IDs
  • 24-007701
NCT ID Number
NCT06972407
Start Date (Actual)
2026-10-01
Last Update Posted
2026-01-30
Completion Date (Estimated)
2029-03-01
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
TCF7L2
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
Exendin 9-39 will be infused during fasting and during a hyperglycemic clamp
Exendin 9-39
A competitive antagonist of the GLP-1 receptor
Placebo ComparatorSaline
Saline will be infused during fasting and during a hyperglycemic clamp
Saline
Saline infusion will serve as an inactive comparator
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in fasting glucose
comparison of fasting glucose during saline vs. exendin 9-39 infusion
Change in average glucose concentration between -30 min and 0 min of each study day (saline day vs. exendin 9-39 day)
Change in fasting glucagon
comparison of fasting glucagon during saline vs. exendin 9-39 infusion
Change in average glucagon concentration between -30 min and 0 min of each study day (saline day vs. exendin 9-39 day)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in fasting insulin
comparison of fasting insulin during saline vs. exendin 9-39 infusion
Change in average insulin concentration between -30 min and 0 min of each study day (saline day vs. exendin 9-39 day)
Change in first phase insulin secretion
comparison of first phase insulin secretion during saline vs. exendin 9-39 infusion
Change in integrated insulin concentrations (area above baseline) between 0 min and 30 min of each study day (saline day vs. exendin 9-39 day)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Subjects with the TT or CC genotype at rs7903146

  1. 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).
  2. CT genotype at rs7903146
  3. HbA1c > 6.5%
  4. Use of any glucose-lowering agents including metformin or sulfonylureas.
  5. For female subjects: positive pregnancy test at the time of enrollment or study.
  6. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  7. Active systemic illness or malignancy.
  8. 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