The Role of Oxytocin in Regulating Blood Glucose

NCT ID: NCT06334172

Last Updated: 2024-04-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.

Detailed Description

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Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) \< 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.

Conditions

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Glucose Metabolism Disorders (Including Diabetes Mellitus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
The randomized order of infusions is blinded to both participant and investigator

Study Groups

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Placebo

Infusion of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Oxytocin 0.1 IU/min

Infusion of oxytocin 0.1 IU/min

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin

Oxytocin 0.2 IU/min

Infusion of oxytocin 0.2 IU/min

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin

Interventions

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Oxytocin

Oxytocin

Intervention Type DRUG

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI 19-25 kg/m2

Exclusion Criteria

* Diabetes
* Heart-, liver or kidney disease
* More than 14 units of alcohol weekly, or drug abuse
* Smoking or any kind of nicotine products
* Alanin aminotransferase (ALAT) ≥ 2 × normal range
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1,73m2 or creatinine above normal range
* Blood pressure \> 140/90
* Hemoglobin \< normal range
* Corrected QT Interval (Qtc) \>0,45 sec. at electrocardiogram (ECG) at screening
* Known disease in the pituitary gland or previous pituitary surgery
* Any other disease/condition which the trial managers believe may affect participation in the trial
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Vivian Kliim-Hansen, MD

Role: CONTACT

+4524476875

Filip Krag Knop

Role: CONTACT

Facility Contacts

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Filip K Knop, MD, PhD

Role: primary

004538674266

Other Identifiers

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H-23071221

Identifier Type: -

Identifier Source: org_study_id

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