The Glucagonotropic Effect of Amino Acids in Humans

NCT ID: NCT05954923

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2023-12-20

Brief Summary

The objective of the study is to delineate the glucagonotropic signal exerted by selected amino acids in human subjects as well as the metabolic clearance rate of these amino acids after intravenous infusion

Detailed Description

After being informed about the study and the potential risks, each participant giving written informed consent will participate in six experimental days. The glucagonotropic effect and metabolic clearance of selected amino acids and saline (placebo), respectively, will be evaluated in 12 healthy individuals. After screening, each participant will undergo 6 double-blinded experimental days performed in randomized order. The experimental days will each last 75 minutes. The amino acids selected for the experiment are glutamine, arginine, alanine, leucine and proline.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Primary arm

This is a single-arm study. Each subject will participate in 6 experimental days in a randomized order. The interventions are equimolar bolus infusions of A) glutamine, B) arginine, C) alanine, D) leucine, E) proline and F) saline (placebo)

Group Type: EXPERIMENTAL

Amino acid bolus infusion

Intervention Type: OTHER

Equimolar bolus infusions of amino acids or saline (placebo)

Interventions

Amino acid bolus infusion

Equimolar bolus infusions of amino acids or saline (placebo)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• normal fasting plasma glucose and glycated hemoglobin (HbA1c) < 42 mmol/mol
• body mass index (BMI) between 18.5 and 25 kg/m2
• Hemoglobin > 8.3 mmol/L
• Age between 20 and 65 years
• oral and written informed consent

Exclusion Criteria

• Diabetes
• first-degree relatives with diabetes
• fasting plasma triglycerides indicating dyslipidemia (> 2 mmol/L)
• nephropathy (eGFR < 60 ml/min) and/or microalbuminuria (albumine/creatinine ratio > 30 microgram/mg)
• liver disease and/or ALT and/or AST levels > 2 x upper normal reference limits.
• signs of liver fibrosis and/or steatosis evaluated by transient elastography (CAP > 238 dB/min) and/or kPa > 6.0) and/or FIB-4 index > 1.45
• regular use of prescription medication
• use of dietary protein supplementation
• any condition the investigator feels would interfere with trial completion

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Novo Nordisk Foundation Center for Basic Metabolic Research

OTHER

Sponsor Role: collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Malte Palm Suppli, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Clinical Metabolic Research

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

STAMINA

Identifier Type: -

Identifier Source: org_study_id