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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06334172
Other study ID # H-23071221
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source University Hospital, Gentofte, Copenhagen
Contact Vivian Kliim-Hansen, MD
Phone +4524476875
Email vivian.kliim-hansen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Oxytocin
Other:
Placebo
Saline

Locations

Country Name City State
Denmark Center for Clinical Metabolic Research, Gentofte Hospital Hellerup Capital Region

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin secretion - c-peptide Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide From time 0 to time 180 min
Secondary Glucose measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary Insulin measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary Glucagon measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary GIP measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary GLP-1 measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary Lipids measured as percentual increase of AUCfor circulating levels From time 0 minutes to time 180 minutes
Secondary Cross-linked C-telopeptide of type I collagen( CTX) measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
Secondary Procollagen type I N-terminal propeptide (P1NP) measured as percentual increase of AUC for circulating levels From time 0 minutes to time 180 minutes
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