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

NCTNCT04461015Other id20-001570

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in the eligibility rules.

Overview

Status: Completed
Phase: Phase 3
Enrollment: 12 participants (actual)
Sponsor: Adrian Vella · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 14 Oct 2020
Primary completion: 30 Jul 2021
Completion: 6 Jan 2022
First posted: 8 Jul 2020
Last update posted: 21 Jun 2022
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 3
The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans
NCT04461015
14 Oct 2020 to 6 Jan 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

0.4mU Insulin followed by withdrawal period followed by 0.8mU studyDrug
0.8mU Insulin followed by withdrawal period followed by 0.4mU studyDrug

Arms2

Other
0.4mU Insulin
During the euglycemic clamp insulin will be infused at 0.4mU/Kg/Min
Other
0.8mU Insulin
During the euglycemic clamp insulin will be infused at 0.8mU/Kg/Min

Primary outcomes1

Outcomes the sponsor listed as primary.

Endogenous Glucose Production (EGP)
Time frame · 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
Registry description
is calculated by tracer-based measurement and expressed per kg lean body mass

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

Endogenous Glucose Production (EGP)

Group	Value (umol/kg/min)	Spread
0.4mU Insulin	4.99	0.53
0.8mU Insulin	5.02	0.74

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
0.4 EventsEvents occurring during the 0.4 euglycemic clamp when insulin was infused at 0.4mU/Kg/Min	0 / 12	0 / 12	1 / 12
0.8 EventsEvents occurring during the 0.8 euglycemic clamp when insulin was infused at 0.8mU/Kg/Min	0 / 12	0 / 12	2 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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