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History of Changes for Study: NCT04459338
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Latest version (submitted October 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 1, 2020 None (earliest Version on record)
2 October 29, 2020 Study Status
3 February 16, 2021 Recruitment Status, Study Status and Contacts/Locations
4 January 3, 2022 Study Status
5 August 1, 2022 Recruitment Status, Study Status and Contacts/Locations
6 October 27, 2022 Study Status
Comparison Format:

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Study NCT04459338
Submitted Date:  July 1, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20-003995
Brief Title: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Official Title: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2020
Overall Status: Not yet recruiting
Study Start: September 2020
Primary Completion: September 2021 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: June 30, 2020
First Submitted that
Met QC Criteria:
July 1, 2020
First Posted: July 7, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
July 1, 2020
Last Update Posted: July 7, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Adrian Vella
Responsible Party: Sponsor-Investigator
Investigator: Adrian Vella
Official Title: Principal Investigator
Affiliation: Mayo Clinic
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the response to elevated glucagon concentrations.
Detailed Description: Glucagon within the islet can signal the β-cell through GLP1R, and acts as an insulin secretagogue. This signaling is blocked by exendin-9,39. The relative importance of glucagon signaling through its cognate receptor or through GLP1R is unknown. Despite the lower affinity of GLP1R for glucagon, intra-islet concentrations of glucagon are sufficiently high to stimulate GLP1R. The other situation where this may occur is in response to pharmacologic doses of glucagon as used for β-cell function testing or raising peripheral glucagon concentrations above fasting values. The experiments proposed will characterize the role of GLP1R in glucagon's actions on the β-cell and the potential therapeutic role of dual (GLP-1R and glucagon receptor) agonists for the treatment of T2DM and obesity.
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 3
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Saline
Saline infused during the hyperglycemic clamp with escalating doses of glucagon
Saline
Placebo comparator
Active Comparator: Exendin-9,39
Exendin-9,39 infused during the hyperglycemic clamp with escalating doses of glucagon
Biological: Exendin-9,39
Exendin-9,39 is a competitive antagonist of GLP-1 actions at the GLP-1 receptor
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Beta-cell responsivity (Φ)
[ Time Frame: It will be quantified hourly during the course of the experiment (0-300 minutes) ]

This is an index of insulin secretion calculated using the minimal modelfor the prevailing glucose concentration.
Open or close this module Eligibility
Minimum Age: 25 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • 20 weight-stable, non-diabetic subjects

Exclusion Criteria:

  • Age < 25 or > 65 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 ≥5.9%
  • Use of glucose-lowering agents.
  • 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.
Open or close this module Contacts/Locations
Study Officials: Adrian Vella, MD
Principal Investigator
Mayo Clinic
Locations: United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: Mayo Clinic Clinical Trials
Available IPD/Information:

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