The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

NCT04232033 | Completed DMC

• 1 other identifier: H-19068397
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibroblast Growth Factor 21; Tast Perference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Plasma glucose concentration

  1 year

• Serum insulin concentration

  1 year

• Plasma fibroblast growth factor-21 concentration

  1 year

• Serum C-peptide concentration

  1 year

• Plasma glucagon concentration

  1 year

Study Arms (2)

Fibroblast growth factor 21 infusion

ACTIVE COMPARATOR

Fibroblast growth factor 21 infusion

Other: Fibroblast growth factor 21 infusion

Placebo infusion (saline)

PLACEBO COMPARATOR

Saline infusion

Other: Placebo infusion (saline)

Interventions

Fibroblast growth factor 21 infusion OTHER

Infusion of Fibroblast growth factor 21

Fibroblast growth factor 21 infusion

Placebo infusion (saline) OTHER

Infusion of Saline

Placebo infusion (saline)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator

Study Sites (1)

Amalie R Lanng

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amalie R Lanng, Dr.

  Center for Clinical Metabolic Research, Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 18, 2020
• Study Start: May 1, 2021
• Primary Completion: June 14, 2022
• Study Completion: December 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)