The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

Fibroblast Growth Factor 21 Clinical Trial

— AlcoPref  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04232033
• Other study ID #: H-19068397
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibroblast Growth Factor 21
• Tast Perference

Intervention

Other:
• Fibroblast growth factor 21 infusion
Infusion of Fibroblast growth factor 21
• Placebo infusion (saline)
Infusion of Saline

Locations

Country	Name	City	State
Denmark	Amalie R Lanng	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	The Novo Nordisk Foundation Center for Basic Metabolic Research

Country where clinical trial is conducted

Denmark, 

Outcome

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