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This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance P - 1nmol/kg | Experimental | Substance P 1nmol/kg intra-celiac artery, single treatment |
|
| Substance P - 5nmol/kg | Experimental | Substance P 5nmol/kg intra-celiac artery, single treatment |
|
| Substance P - 15nmol/kg | Experimental | Substance P 15nmol/kg intra-celiac artery, single treatment |
|
| Substance P - 45nmol/kg | Experimental | Substance P 45nmol/kg intra-celiac artery, single treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Substance P | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage A Safety: Side effects reported for entire cohort | To determine if there are unexpected adverse events with intra arterial delivery of sP into the celiac artery in individuals with Type 1 Diabetes, and evidence of residual beta cell function as reflected by a peak C---peptide levels of > 200 pmol/L. Multiple measurements per patient will be aggregated to arrive at one reported value: Number of participants with abnormal laboratory values, adverse events and/or peak C-peptide levels >200pmol/L that are related to treatment. | Reported during the first 20-27 days following sP administration |
| Measure | Description | Time Frame |
|---|---|---|
| C-Peptide Levels (small cohort) | To determine in an initial small cohort (n=12, toxicity and dose finding cohort) if one or more sP doses significantly increases the basal or stimulated c---Peptide levels at Day 20---27 post---injection using data from Mixed Meal Tolerance Test (MMTT). | Day 20-27 post sP injection |
| Measure | Description | Time Frame |
|---|---|---|
| sP Longevity | To determine an estimate of sP longevity in the entire cohort of patients, by monitoring HbA1c values, exogenous insulin requirement, daily recorded blood sugar levels and adverse event recording at 3 and 6 months post injection of sP. Multiple measurements per patient will be aggregated to arrive at one reported value for the aforementioned outcome measures. | 3 and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Tschirhart | Contact | 416-813-7654 | 204517 | holly.tschirhart@sickkids.ca |
| Catherine Pastor | Contact | 416-813-7654 | 204396 |
| Name | Affiliation | Role |
|---|---|---|
| Etienne Sochett, MD | Hospital for Sick Children, Toronto Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Sick Children | Recruiting | Toronto | Ontario | Canada |
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| Label | URL |
|---|---|
| CDA 2013 guidelines | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013373 | Substance P |
| ID | Term |
|---|---|
| D015320 | Tachykinins |
| D007705 | Kinins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| C-Peptide Levels (large cohort) |
To assess in a larger cohort (n=40, continued safety and efficacy) whether sP dose, determined from the dose finding cohort, significantly increases basal or stimulated C-- peptide levels at Day 20---27 post sP---injection using MMTT data. |
| Day 20-27 post sP injection |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |