The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism (AlcoPref)

The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men

The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).

Study Overview

• Status: Active, not recruiting
• Conditions: Fibroblast Growth Factor 21; Tast Perference
• Intervention / Treatment: Other: Fibroblast growth factor 21 infusion; Other: Placebo infusion (saline)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Amalie R Lanng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Informed consent
• Caucasian male
• Body mass index between 19 and 27 kg/m2
• Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (< 42 mmol/mol)
• Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)

Exclusion Criteria:

• Liver diseases evaluated by plasma alanine aminotransferase (ALAT) > 3 × normal level or an International Normalized Ratio (INR) below normal values
• Diabetes mellitus
• Nephropathy
• First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder
• Other diseases the investigator finds disruptive for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fibroblast growth factor 21 infusion	Other: Fibroblast growth factor 21 infusion; Infusion of Fibroblast growth factor 21
Placebo Comparator: Placebo infusion (saline); Saline infusion	Other: Placebo infusion (saline); Infusion of Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol preference (How much do you want to drink alcohol?)	Evaluated by Visual analogue scale from "not at all" to "more than ever"	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose concentration	Plasma glucose concentration	1 year
Serum insulin concentration	Serum insulin concentration	1 year
Plasma fibroblast growth factor-21 concentration	Plasma fibroblast growth factor-21 concentration	1 year
Serum C-peptide concentration	Serum C-peptide concentration	1 year
Plasma glucagon concentration	Serum C-peptide concentration	1 year
Plasma lipid profile	Plasma concentrations of triglycerides, total cholesterol, free fatty acids	1 year
Plasma insulin-like growth factor 1 concentration	Plasma insulin-like growth factor 1 concentration	1 year
Plasma bone marker concentration	Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide	1 year
Resting energy expenditure	Evaluated by indirect calorimetry	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: The Novo Nordisk Foundation Center for Basic Metabolic Research
• Investigators: Principal Investigator: Amalie R Lanng, Dr., Center for Clinical Metabolic Research, Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 14, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: H-19068397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No