Glucose Metabolism Disorders (Including Diabetes Mellitus) Clinical Trial
— GLOXY-1Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Metabolic Research, Gentofte Hospital | Hellerup | Capital Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
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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