The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

Not Applicable

Completed

• Conditions: Tast Perference; Fibroblast Growth Factor 21
• Interventions: Other: Placebo infusion (saline); Other: Fibroblast growth factor 21 infusion

• Registration Number: NCT04232033
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2021-05-01
• Primary Completion: 2022-06-14
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo infusion (saline)	Placebo infusion (saline)	Saline infusion
Fibroblast growth factor 21 infusion	Fibroblast growth factor 21 infusion	Fibroblast growth factor 21 infusion

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amalie R Lanng; 🇩🇰 Hellerup, Denmark