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NCT Number: NCT06334172

The Role of Oxytocin in Regulating Blood Glucose

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

Recruiting

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

Location status: Recruiting

Location contact

Filip K Knop, MD, PhD

CONTACT

[email protected]

004538674266

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Oxytocin

Placebo

Other

Saline

Primary outcomes

  1. Insulin secretion - c-peptide

    Time frame: From time 0 to time 180 min

    Insulin secretion, measured as percentual increase of area under the curve (AUC) for circulating c-peptide

Secondary outcomes

  1. Glucose

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  2. Insulin

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  3. Glucagon

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  4. GIP

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  5. GLP-1

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  6. Lipids

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUCfor circulating levels

  7. Cross-linked C-telopeptide of type I collagen( CTX)

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

  8. Procollagen type I N-terminal propeptide (P1NP)

    Time frame: From time 0 minutes to time 180 minutes

    measured as percentual increase of AUC for circulating levels

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Krag Knop

CONTACT

[email protected]

Vivian Kliim-Hansen, MD

CONTACT

[email protected]

+4524476875

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: GLOXY-1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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