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The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

NCT ID: NCT04232033

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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Fibroblast Growth Factor 21 Tast Perference

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fibroblast growth factor 21 infusion

Fibroblast growth factor 21 infusion

Group Type ACTIVE_COMPARATOR

Fibroblast growth factor 21 infusion

Intervention Type OTHER

Infusion of Fibroblast growth factor 21

Placebo infusion (saline)

Saline infusion

Group Type PLACEBO_COMPARATOR

Placebo infusion (saline)

Intervention Type OTHER

Infusion of Saline

Interventions

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Fibroblast growth factor 21 infusion

Infusion of Fibroblast growth factor 21

Intervention Type OTHER

Placebo infusion (saline)

Infusion of Saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Novo Nordisk Foundation Center for Basic Metabolic Research

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amalie R Lanng, Dr.

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Metabolic Research, Gentofte Hospital

Locations

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Amalie R Lanng

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-19068397

Identifier Type: -

Identifier Source: org_study_id