Trial Outcomes & Findings for The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA (NCT NCT03965130)

NCT ID: NCT03965130

Last Updated: 2024-11-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: 5 hours
• Results posted on: 2024-11-26

Participant Flow

Participant milestones

Measure	Glucagon Participants will receive glucagon or saline during the PINTA study Glucagon: PINTA study with or without glucagon
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Glucagon n=10 Participants Participants will receive glucagon or saline during the PINTA study Glucagon: PINTA study with or without glucagon
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Hepatic mitochondrial function	149 micromol per min STANDARD_DEVIATION 49 • n=5 Participants

PRIMARY outcome

Timeframe: 5 hours

Population: Each arm is comprised of the same 10 participants from the crossover design.

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

Outcome measures

Measure	Glucagon n=10 Participants Participants will receive glucagon or saline during the PINTA study Glucagon: PINTA study with or without glucagon	Saline n=10 Participants Participants will receive glucagon or saline during the PINTA study Glucagon: PINTA study with or without glucagon
Rates of Hepatic Mitochondrial Oxidation	262 micromol/min Standard Error 33	149 micromol/min Standard Error 15

Adverse Events

Glucagon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kitt Falk Petersen

Yale

Phone: 203 737 1942

Email: kitt.petersen@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60