The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans

NCT04461015 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20-001570
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to help understand the relative importance of changes in insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to regulate metabolism and the body's ability to make glucose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Endogenous Glucose Production (EGP)

  is calculated by tracer-based measurement and expressed per kg lean body mass

  It will be quantified at 90, 180 and 270 minutes for the study with 0.4mU insulin infusion and compared to values obtained for the study with 0.8mU insulin infusion at the same timepoints

Study Arms (2)

0.4mU Insulin

OTHER

During the euglycemic clamp insulin will be infused at 0.4mU/Kg/Min

Drug: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study; Drug: 0.8mU Insulin followed by withdrawal period followed by 0.4mU study

0.8mU Insulin

OTHER

During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min

Drug: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study; Drug: 0.8mU Insulin followed by withdrawal period followed by 0.4mU study

Interventions

0.4mU Insulin followed by withdrawal period followed by 0.8mU study DRUG

Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min

Also known as: 0.4 then 0.8

0.4mU Insulin; 0.8mU Insulin

0.8mU Insulin followed by withdrawal period followed by 0.4mU study DRUG

Clamp study with insulin infused at 0.8 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.4 mU/Kg/min

Also known as: 0.8 then 0.4

0.4mU Insulin; 0.8mU Insulin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• We will recruit 15 otherwise healthy subjects using intramural and local extramural advertising after approval from the Mayo Clinic Institutional Review Board. Individuals who express interest in participating will be invited for a screening visit. Individuals with a BMI \< 19 or \> 28 kg/m2 will be excluded from the study to avoid potential confounding effects that may result from extreme leanness or from obesity. Subjects will have no known systemic illness, taking any medication that could affect glucose metabolism and no history of upper gastrointestinal surgery.

You may not qualify if:

• Subjects \< 18 years of age or \> 40 years of age will not be studied to minimize the potential confounding effects of age on glucagon and insulin action. The subjects will not be taking medications that affect glucose metabolism (to be determined by PI) and have no history of chronic illness or upper gastrointestinal surgery. We are seeking to recruit subjects who do not have diabetes (fasting glucose \<100mg/dL).

Sponsors & Collaborators

• Adrian Vella: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Limitations and Caveats

The main caveat is that during the experiment insulin is kept constant - i.e. not quite like what happens in the postprandial situation

Results Point of Contact

• Title: Adrian Vella
• Organization: Mayo Clinic

vella.adrian@mayo.edu

507-255-6515

Study Officials

• Adrian Vella

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 8, 2020
• Study Start: October 14, 2020
• Primary Completion: July 30, 2021
• Study Completion: January 6, 2022
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)