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| ID | Type | Description | Link |
|---|---|---|---|
| H-18015379 | Other Identifier | Research Ethics in the Capital of Denmark |
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In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose-Dependent Insulinotropic Polypeptide | Active Comparator | 6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide |
|
| Placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIP | Drug | Infusion of Glucose-dependent insulinotropic peptide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose | Time spent in hypoglycemia, near-normoglycemia and hyperglycemia | an average of 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incretin hormones | Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve | Evaluated at experimental day 0,1 and 6 of each intervention |
| Free fatty acids (FFA) |
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Inclusion Criteria:
Exclusion Criteria:
Caucasian men
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology | Hellerup | 2800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40004948 | Derived | Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619. | |
| 36111559 | Derived | Heimburger SMN, Hoe B, Nielsen CN, Bergman NC, Skov-Jeppesen K, Hartmann B, Holst JJ, Dela F, Overgaard J, Storling J, Vilsboll T, Dejgaard TF, Havelund JF, Gorshkov V, Kjeldsen F, Faergeman NJ, Madsen MR, Christensen MB, Knop FK. GIP Affects Hepatic Fat and Brown Adipose Tissue Thermogenesis but Not White Adipose Tissue Transcriptome in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3261-3274. doi: 10.1210/clinem/dgac542. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 14, 2025 | |
| Reset | Mar 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 14, 2025 | Mar 6, 2025 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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placebo-controlled, double-blinded, cross-over study
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The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant.
Incremental and total area under the Concentration-Time Curve
| Evaluated at experimental day 0,1 and 6 of each intervention |
| Fat mRNA | mRNA analysis of fat biopsies | At day 6, and 10 of the study |
| Fat Protein content | Protein analysis of fat biopsies | Evaluated at experimental day 0,1 and 6 of each intervention |
| Blood pressure | Changes in blood pressure, mm Hg | The first 24 hours of intervention and at experimental day 6 |
| Pulse | Changes in pulse, beats per minute | The first 24 hours of intervention and at experimental day 6 |
| Glucose regulatory hormones | Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve | Evaluated at experimental day 0,1 and 6 of each intervention |
| Number of symptomatic hypoglycemic events | Self-reported events | An average of 1 week |
| 34405256 | Derived | Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17. |