Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-24080204 | Other Identifier | The Danish Health Research Ethics Committee system |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.
Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design. This will determine the effect of oxytocin on the glucagon response to hypoglycemia. Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusion of placebo | Placebo Comparator | Placebo |
|
| Infusion of oxytocin | Experimental | Infusion of oxytocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Saline |
| |
| Oxytocin |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon secretion | Glucagon secretion, measured as the difference in plasma glucagon response to hypoglycaemia (as assessed by baseline subtracted area under curve (bsAUC)) during the hypoglycaemic clamp, between study days with oxytocin and with placebo | From time 30 to time 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon during recovery | measured as difference in glucagon bsAUC in the recovery phase | From time 90 minutes to time 135 minutes |
| Glucagon during the entire period | measured as difference in glucagon bsAUC in the intire period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Hellerup | 2900 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls
Not provided
Not provided
The randomized order of infusions is blinded to both participant and investigator
| Drug |
Oxytocin |
|
| From time 0 minutes to time 135 minutes |
| Glucose infusion | measured as the total amount of glucose infused | From time 0 minutes to time 135 minutes |
| Insulin | measured as the difference in circulating levels of insulin between study days | From time 0 minutes to time 135 minutes |
| c-peptide | measured as the difference in circulating levels of c-peptide between study days | From time 0 minutes to time 135 minutes |
| Epinephrine | measured as the difference in circulating levels of epinephrine between study days | From time 0 minutes to time 135 minutes |
| Norepinephrine | measured as the difference in circulating levels of norepinephrine between study days | From time 0 minutes to time 135 minutes |
| Cortisol | measured as the difference in circulating levels of cortisol between study days | From time 0 minutes to time 135 minutes |
| Cross-linked C-telopeptide of type I collagen( CTX) | measured as the difference in circulating levels of CTX between study days | From time 0 minutes to time 135 minutes |
| Procollagen type I N-terminal propeptide (P1NP) | measured as the difference in circulating levels of P1NP between study days | From time 0 minutes to time 135 minutes |
| Growth Hormone (GH) | measured as the difference in circulating levels of GH between study days | From time 0 minutes to time 135 minutes |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |