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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 patients with T1D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIP | Active Comparator | Infusion of Glucose-dependent insulinotropic peptide |
|
| GIP[3-30] | Active Comparator | Infusion of GIP[3-30] |
|
| Saline | Placebo Comparator | Infusion of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose-dependent insulinotropic peptide | Drug | Infusion of GIP |
| |
| Measure | Description | Time Frame |
|---|---|---|
| plasma glucose concentration | plasma glucose excursions and plasma glucose nadir | At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose regulatory hormones | Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| Incretin hormones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filip K Knop, MD, PhD | Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology | Hellerup | 2900 | Denmark |
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Double blinded, randomized, cross-over study
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The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant..
| Glucose-Dependent Insulin-Releasing Hormone[3-30] |
| Drug |
Infusion of GIP antagonist GIP[3-30] |
|
| Saline Solution | Drug | Infusion of Saline |
|
|
Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve |
| At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| GIP[3-30] | GIP[3-30]. Incremental and total area under the Concentration-Time Curve | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| Free fatty acids (FFA) | Free fatty acids(FFA). Incremental and total area under the Concentration-Time Curve | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| Blood analysis of paracetamol as an assessment of gastric emptying | Assessment of gastric emptying | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| Fat mRNA | Fat biopsy to evaluate changes in fat mRNA | At time 240 minute on study days |
| Fat Lipoprotein lipase (LPL) | Fat biopsy to evaluate LPL changes in fat | At time 240 minute on study days |
| Fat Perilipin 4 | Fat biopsy to evaluate Perilipin 4 changes in fat | At time 240 minute on study days |
| Fat Fatty acid binding protein 4 (FABP4) | Fat biopsy to evaluate Fatty acid binding protein 4 (FABP4) changes in fat | At time 240 minute on study days |
| Fat Hormonse-sensitive lipase (HSL) | Fat biopsy to evaluate Hormonse-sensitive lipase (HSL) changes in fat | At time 240 minute on study days |
| Fat Vascular endothelial growth factor 4 (VEGF-A) | Fat biopsy to evaluate Vascular endothelial growth factor 4 (VEGF-A) changes in fat | At time 240 minute on study days |
| Fat GIP receptor (GIPR) | Fat biopsy to evaluate GIP receptor (GIPR) changes in fat | At time 240 minute on study days |
| Blood pressure | Changes in blood pressure, mm Hg | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| Pulse | Changes in pulse, beats per minute | At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005749 | Gastric Inhibitory Polypeptide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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