Healthy ParticipantsPhase 1NCT03965130
The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA
A Phase 1 study testing Glucagon in people with Healthy Participants, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Glucagon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 6 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Non smoking
- Taking no medications except birth control
Who cannot join
- Any systemic or organ disease
- Smoking
- Taking any drug or medications other than birth control (women)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Hospital reserach Unit / YCCI
New Haven, Connecticut, 06520
About this study
Official title: The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation and Pyruvate Carboxylase Flux in Man Assessed by Positional Isotopomer NMR Tracer Analysis (PINTA)
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.
Read the detailed description
Objectives:
To examine rates of hepatic mitochondrial oxidation in healthy volunteers with liver lipid less than 2%.
To examine the effects of glucagon on hepatic glucose and fat metabolism in vivo, this study will apply a novel Positional Isotopomer NMR Tracer Analysis (PINTA) method to quantify rates of hepatic mitochondrial oxidation and pyruvate carboxylase flux, which has been cross-validated in awake rodents and humans (Perry et al. Nature Communications 2017). Preliminary rodent studies have found that glucagon stimulates intrahepatic lipolysis through an InsP3R-I-dependent process, leading to increases in hepatic acetyl-CoA content, which allosterically activates pyruvate carboxylase activity and flux, and that this phenomenon explains its acute, transcription-independent effect to acutely stimulate hepatic gluconeogenesis in vivo (unpublished results). In addition, using PINTA analysis it has been shown that glucagon stimulates hepatic mitochondrial oxidation through calcium signaling in awake mice, and that this process can be exploited by short-term continuous glucagon treatment leading to two-fold increases in hepatic mitochondrial fat oxidation, which in turn results in large reductions in hepatic steatosis and marked improvements in glucose tolerance through reversal of hepatic insulin resistance in a high fat fed rat model of non alcoholic fatty liver.
Hypothesis:
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of hepatic mitochondrial oxidation in healthy humans.
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of hepatic pyruvate carboxylase flux in healthy humans.
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of 13C4 β-hydroxybutyrate turnover (hepatic ketogenesis) in healthy humans.
Study Design - Clinical Plan:
The effects of a physiological increase in plasma glucagon on rates of hepatic mitochondrial oxidation and pyruvate carboxylase flux will be examined in a group of up to 12 healthy participants (ages 21-65) using Positional Isotopomer NMR Tracer Analysis (PINTA) (Perry et al. Nature Communication 2017). Briefly rates of hepatic mitochondrial oxidation and hepatic pyruvate carboxylase flux will be assessed in 12 healthy overnight fasted participants by PINTA after a three-hour infusion of glucagon or saline. The glucagon infusion will be designed to increase peripheral and portal vein plasma glucagon concentrations 3-4 fold. The effects of a physiological increase in plasma glucagon on rates of hepatic ketogenesis will also be assessed using an infusion of 13C4 β-betahydroxybutyrate (Perry et al. Cell Metabolism 2017).
Rates of hepatic pyruvate carboxylase flux /citrate synthase flux by PINTA: Participants (n=12) will be studied by PINTA under 2 conditions: 1) following an overnight fast and a 3 hour saline infusion (Control), 2) following an overnight fast and a 3 hour glucagon infusion. Briefly, after collection of baseline blood samples a 3 hour infusion of tracers as described below will be started. Relative rates of pyruvate carboxylase to citrate synthesis flux will be assessed using a constant infusion of [3-13C] lactate and rates of glucose production will be measured using an infusion of [2H7]glucose (Perry et al. Nature Communication 2017). Rates of hepatic ketogenesis will be measured using a constant infusion of [3C β-hydroxybutyrate as previously described (Perry et al. Cell Metabolism 2017).
Whole body energy expenditure and the respiratory quotient will be assessed by indirect calorimetry.
- Conditions
- Healthy Participants
- Being tested
- Glucagon, Control Study
- Keywords
- Hepatic Glucose Metabolism, Hepatic Mitochondrial Oxidation, PINTA, Glucagon
- Medical subject headings
- Pinta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonBiological
Also called hormone study
PINTA study with glucagon
Control StudyOther
Also called No glucagon
The same participants will not receive glucagon during the PINTA study
| Study group | Role | What they receive |
|---|---|---|
| Glucagon | Experimental | Participants will receive glucagon during the PINTA study Receives: Biological: Glucagon |
| Control | Experimental | The same participants will not receive glucagon during the PINTA study Receives: Other: Control Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Hepatic Mitochondrial Oxidation
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
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start5 Jun 2019
- Primary completion7 Jul 2022
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will participate in two studies: one without and one with a 3 hour infusion of glucagon during the PINTA study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Kitt F Petersen, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965130
- Sponsor's protocol ID
- 0209020997_a
- Other IDs
- MISP58340
- Status last verified
- Nov 2024
- First submitted
- 23 May 2019
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Final data to be shared with study sponsor
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation and Pyruvate Carboxylase Flux in Man Assessed by Positional Isotopomer NMR Tracer Analysis (PINTA)
- ClinicalTrials.gov ID
- NCT03965130
- Acronym / sponsor ID
- 0209020997_a
- Conditions
- Healthy Participants
- Keywords
- Hepatic Glucose Metabolism, Hepatic Mitochondrial Oxidation, PINTA, Glucagon
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
To examine rates of hepatic mitochondrial oxidation in healthy volunteers with liver lipid less than 2%.
To examine the effects of glucagon on hepatic glucose and fat metabolism in vivo, this study will apply a novel Positional Isotopomer NMR Tracer Analysis (PINTA) method to quantify rates of hepatic mitochondrial oxidation and pyruvate carboxylase flux, which has been cross-validated in awake rodents and humans (Perry et al. Nature Communications 2017). Preliminary rodent studies have found that glucagon stimulates intrahepatic lipolysis through an InsP3R-I-dependent process, leading to increases in hepatic acetyl-CoA content, which allosterically activates pyruvate carboxylase activity and flux, and that this phenomenon explains its acute, transcription-independent effect to acutely stimulate hepatic gluconeogenesis in vivo (unpublished results). In addition, using PINTA analysis it has been shown that glucagon stimulates hepatic mitochondrial oxidation through calcium signaling in awake mice, and that this process can be exploited by short-term continuous glucagon treatment leading to two-fold increases in hepatic mitochondrial fat oxidation, which in turn results in large reductions in hepatic steatosis and marked improvements in glucose tolerance through reversal of hepatic insulin resistance in a high fat fed rat model of non alcoholic fatty liver.
Hypothesis:
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of hepatic mitochondrial oxidation in healthy humans.
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of hepatic pyruvate carboxylase flux in healthy humans.
- A physiological increase in plasma glucagon concentrations will promote a significant increase in rates of 13C4 β-hydroxybutyrate turnover (hepatic ketogenesis) in healthy humans.
Study Design - Clinical Plan:
The effects of a physiological increase in plasma glucagon on rates of hepatic mitochondrial oxidation and pyruvate carboxylase flux will be examined in a group of up to 12 healthy participants (ages 21-65) using Positional Isotopomer NMR Tracer Analysis (PINTA) (Perry et al. Nature Communication 2017). Briefly rates of hepatic mitochondrial oxidation and hepatic pyruvate carboxylase flux will be assessed in 12 healthy overnight fasted participants by PINTA after a three-hour infusion of glucagon or saline. The glucagon infusion will be designed to increase peripheral and portal vein plasma glucagon concentrations 3-4 fold. The effects of a physiological increase in plasma glucagon on rates of hepatic ketogenesis will also be assessed using an infusion of 13C4 β-betahydroxybutyrate (Perry et al. Cell Metabolism 2017).
Rates of hepatic pyruvate carboxylase flux /citrate synthase flux by PINTA: Participants (n=12) will be studied by PINTA under 2 conditions: 1) following an overnight fast and a 3 hour saline infusion (Control), 2) following an overnight fast and a 3 hour glucagon infusion. Briefly, after collection of baseline blood samples a 3 hour infusion of tracers as described below will be started. Relative rates of pyruvate carboxylase to citrate synthesis flux will be assessed using a constant infusion of [3-13C] lactate and rates of glucose production will be measured using an infusion of [2H7]glucose (Perry et al. Nature Communication 2017). Rates of hepatic ketogenesis will be measured using a constant infusion of [3C β-hydroxybutyrate as previously described (Perry et al. Cell Metabolism 2017).
Whole body energy expenditure and the respiratory quotient will be assessed by indirect calorimetry.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will participate in two studies: one without and one with a 3 hour infusion of glucagon during the PINTA study
| Arm | Type | Receives |
|---|---|---|
| Glucagon | Experimental | Biological: GlucagonParticipants will receive glucagon during the PINTA study |
| Control | Experimental | Other: Control StudyThe same participants will not receive glucagon during the PINTA study |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Non smoking
- Taking no medications except birth control
Key exclusion criteria (3 listed)
- Any systemic or organ disease
- Smoking
- Taking any drug or medications other than birth control (women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucagonAlso: hormone studyPINTA study with glucagon | Biological | Glucagon |
| Control StudyAlso: No glucagonThe same participants will not receive glucagon during the PINTA study | Other | Control |
Primary outcome
Rates of Hepatic Mitochondrial Oxidation
Time frame: 5 hours
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Final data to be shared with study sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kitt F Petersen, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucagon in people with Healthy Participants, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Hepatic Mitochondrial Oxidation (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.