The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA

NCTNCT03965130Other id0209020997_aOther idMISP58340

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 10 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 5 Jun 2019
Primary completion: 7 Jul 2022
Completion: 6 Jul 2023
First posted: 28 May 2019
Last update posted: 26 Nov 2024
Conditions: Healthy Participants

Timeline

1 trial · 1 completed · 1 with posted results

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

201920202021202220232024

Ph 1
The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA
NCT03965130
5 Jun 2019 to 6 Jul 2023

Registry summary

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

It is well established that alterations in the portal vein insulin:glucagon ratio play a major role in the dysregulated hepatic glucose metabolism in type 2 diabetes but the molecular mechanism by which glucagon promotes alterations in hepatic glucose production and mitochondrial oxidation remain poorly understood. This is borne out of the fact that both glucagon agonists and antagonists are being developed to treat type 2 diabetes with unclear mechanisms of action. This study will directly assess rates of mitochondrial oxidation and pyruvate carboxylase flux for the first time in humans using PINTA analysis as well as the effects of glucagon. The results will have important implications for the possibility of intervening in the pathogenesis of non alcoholic fatty liver and type 2 diabetes via chronic dual GLP-1/glucagon receptor antagonism and provide an important rationale for why a dual agonist may be more efficacious for treatment of non alcoholic fatty liver and T2D than GLP-1 alone.

Interventions

GlucagonBiological
Control StudyOther

Arms2

Experimental
Glucagon
Participants will receive glucagon during the PINTA study
Experimental
Control
The same participants will not receive glucagon during the PINTA study

Primary outcomes1

Outcomes the sponsor listed as primary.

Rates of Hepatic Mitochondrial Oxidation
Time frame · 5 hours
Registry description
Rates of pyruvate carboxylase flux and citrate synthesis flux will be assessed using GC/MS and NMR analyses of plasma glucose 13C enrichments after the \[3-13C\]lactate infusion

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· 5 hours

Rates of Hepatic Mitochondrial Oxidation

Group	Value (micromol/min)	Spread
Glucagon	262	33
Saline	149	15

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GlucagonParticipants will receive glucagon in the PINTA study	0 / 10	0 / 10	0 / 10
ControlThe same participants will not receive glucagon during the PINTA study.	0 / 10	0 / 10	0 / 10

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 21 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Healthy * Non smoking * Taking no medications except birth control Exclusion Criteria: * Any systemic or organ disease * Smoking * Taking any drug or medications other than birth control (women)

PepBank is a research reference. Talk to a doctor before you use any peptide.