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Not yet recruiting NCT07350512

Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants

No phase Interventional Glucose Metabolism Glucagon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: alanine.
Who it may be relevant to
Registry conditions: Glucose Metabolism, Glucagon. Basic parameters: 25 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study

Overview

In this study the investigators will investigate the acute effects of increasing alanine exposure on metabolic parameters in healthy participants. Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.

Detailed description

Two peripheral catheters will be placed in the antecubital vein of each arm for infusion of L-alanine and blood sampling respectively. The infusion rate of alanine will start at 1.4 μmol/kg/min and increase every 30 minutes over a 3-hour period, up to a maximum of 28 μmol/kg/min. The study day will last approximately 4 hours, and a maximal blood volume of 130 ml will be collected. Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.

Interventions

  • Other alanine
    A three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min)

Primary outcome measures

  • Threshold alanine infusion rate for stimulation of plasma glucagon [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
Secondary outcome measures (9)
  • Change in plasma glucose during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma follicle-stimulating hormone (FSH) during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma luteinizing hormone (LH) during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma cortisol during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma triglycerides during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma urea during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma alanine aminotransferase (ALAT) during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma C-peptide during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]
  • Change in plasma insulin during stepwise alanine infusion [Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.]

Eligibility criteria

Inclusion criteria

  • Capable of understanding the participant information and signing the consent form
  • Between 25 and 70 years of age at the time of screening
  • Body mass index (BMI) ≤ 25 kg/m2 at the time of screening

Exclusion criteria

  • Enrolment in other research projects that might interfere with the study
  • Diabetes diagnosis (type 1 and 2)
  • Pregnancy or breastfeeding
  • Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
  • Impaired liver function defined as either alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥ 2 times normal values
  • Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female
  • Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range 90-150 mmHg for systolic and 50-100 mmHg for diastolic
  • Active or recent malignant disease
  • Current or history of severe alcohol use or drug/chemical abuse as per investigator's judgement
  • Any chronic disorders or severe diseases which, in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frede — Copenhagen

Identifiers

NCT: NCT07350512 · GluCoMet_stepwise alanine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗