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HealthyPhase 4NCT05264727

Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion

A Phase 4 study testing Dextrose and Clinisol 15% in people with Healthy and Type 2 Diabetes, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is being done to better understand how amino acids alter the release of glucagon and insulin compared to glucose alone in health and disease. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Type 2 Diabetes, Obesity
What is being tested?
Dextrose and Clinisol 15%
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 May 2023to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • HbA1c ≤ 8.5% (type 2 diabetic subjects).
  • HbA1c ≤ 6.5% (obese and lean subjects).
  • BMI ≥ 28 Kg/M^2 (Obese subjects with and without type 2 diabetes).
  • BMI ≤ 25 Kg/M^2 (Lean subjects without type 2 diabetes).
  • Use of sulfonylureas or metformin only (type 2 diabetec subjects).
  • For female subjects: negative pregnancy test at the time of enrollment or study.
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  • No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • No active systemic illness or malignancy.
  • No symptomatic macrovascular or microvascular disease.
  • No contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit > 35%.
  • TSH > 0.4 or < 5.5.
  • Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.
  • BMI ≤ 25 Kg/M^2).

Who cannot join

  • HbA1c ³ 8.5%
  • BMI ≤ 28 Kg/M2
  • Use of insulin or agents other than sulfonylureas or metformin.
  • For female subjects: positive pregnancy test at the time of enrollment or study
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
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  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
  • Inclusion Criteria - Obese Subjects without Type 2 Diabetes:
  • BMI ≥ 28 Kg/M2.
  • > 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.
  • Exclusion Criteria - Obese Subjects without Type 2 Diabetes:
  • HbA1c ≥ 6.5%
  • BMI ≤ 28 Kg/M2
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
  • HbA1c ≥ 6.5%.
  • BMI ≥ 25 Kg/M^2.
  • Use of any glucose-lowering agents including metformin or sulfonylureas.
  • For female subjects: positive pregnancy test at the time of enrollment or study.
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g., metal implants, claustrophobia).
  • Hematocrit < 35%.
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
  • Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

This study is being done to better understand how amino acids alter the release of glucagon and insulin compared to glucose alone in health and disease.

Read the detailed description

T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing endogenous glucose production (EGP). In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA concentrations. Are the elevated concentrations of branched-chain AA and other AA metabolites in T2DM a cause or an effect of global α-cell dysfunction? To measure glucagon secretion, as well as glucagon action, we have developed a population model of glucagon kinetics allowing us to deconvolve secretion from glucagon concentrations in a manner similar to Van Cauter's model for insulin secretion from C-peptide. This enables better characterization of α-cell function in humans. In addition to our novel methodology, we can characterize α-cell responsiveness to a graded glucose infusion, by quantifying (G50) - the change in glucose concentration necessary to suppress glucagon secretion by 50%. These experiments will determine if the glucagon secretion in response to AA differs in obese individuals with T2DM from that observed in obese individuals without T2DM.

Being tested
Dextrose, Clinisol 15%
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DextroseDrug

    Intravenous graded glucose infusion using 50% dextrose will commence at 1mg/kg/min and increase to 2 (0900), 4 (1000) and 8mg/kg/min (1100) every 60 minutes

  • Clinisol 15%Drug

    Also called Amino Acid Mixture

    Intravenous infusion 0.003ml/kg/min infused from 0 to 240 minutes

Study groups in NCT05264727
Study groupRoleWhat they receive
Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Saline and GlucoseExperimentalStudy visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of saline and glucose (50%) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.
Receives: Drug: Dextrose
Healthy Adults, Obese Adults, Adults with Type 2 diabetes: Amino Acid and GlucoseExperimentalStudy visit: Subjects will receive a caffeine free, standardized evening meal and remain fasting overnight. An IV infusion of glucose (50%) will be given the next morning together with an IV infusion of Clinisol 15% (an amino acid mixture) will be given the next morning and continue until the end of study. Blood draws will be collected frequently from the IV line to monitor blood glucose levels.
Receives: Drug: Dextrose; Drug: Clinisol 15%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glucagon Suppression (G50) caused by amino acids vs. saline

    concentration of glucose necessary to suppress glucagon by 50%

    Measured: 240 minutes of study

Secondary outcomes (2)

  1. Glucagon suppression (G50) is greater in people with T2DM

    concentration of glucose necessary to suppress glucagon by 50%

    Measured: 240 minutes of study

  2. glucagon suppression (G50) is greater in obese compared to lean people without T2DM

    concentration of glucose necessary to suppress glucagon by 50%

    Measured: 240 minutes of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start30 May 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264727
Sponsor's protocol ID
22-000306
Other IDs
R01DK116231
Status last verified
Feb 2026
First submitted
22 Feb 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dextrose and Clinisol 15% in people with Healthy and Type 2 Diabetes, run by Mayo Clinic 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 14 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Change in Glucagon Suppression (G50) caused by amino acids vs. saline (time frame: 240 minutes of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264727.

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 13 Feb 2026.

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