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Trial record 2 of 6 for:    celiac disease AND Toronto

Neuropeptide Therapy of Recent Onset Type 1 Diabetes

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Vanilloid Genetics Inc.
Sponsor:
Information provided by (Responsible Party):
Vanilloid Genetics Inc.
ClinicalTrials.gov Identifier:
NCT02820558
First received: May 19, 2016
Last updated: June 28, 2016
Last verified: June 2016
  Purpose
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.

Condition Intervention Phase
Diabetes Mellitus, Type 1 Drug: Substance P Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)

Resource links provided by NLM:


Further study details as provided by Vanilloid Genetics Inc.:

Primary Outcome Measures:
  • Stage A Safety: Side effects reported for entire cohort [ Time Frame: Reported during the first 20-27 days following sP administration ]
    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.


Secondary Outcome Measures:
  • C-Peptide Levels (small cohort) [ Time Frame: Day 20-27 post sP injection ]
    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).

  • C-Peptide Levels (large cohort) [ Time Frame: Day 20-27 post sP injection ]
    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.


Other Outcome Measures:
  • sP Longevity [ Time Frame: 3 and 6 months ]
    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.


Estimated Enrollment: 12
Study Start Date: May 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Substance P - 1nmol/kg
Substance P 1nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Experimental: Substance P - 5nmol/kg
Substance P 5nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Experimental: Substance P - 15nmol/kg
Substance P 15nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Experimental: Substance P - 45nmol/kg
Substance P 45nmol/kg intra-celiac artery, single treatment
Drug: Substance P

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent onset T1D (CDA 2013 guidelines: See link in links section
  • Age 10-18 years
  • Disease Duration 3-30 months
  • Fasting C-Peptide (measured at screening) greater than or equal to 33 pmol/L
  • Post honeymoon phase based on the following criteria: History of HbA1c values and insulin requirements from diagnosis indicating a honeymoon period followed by increased insulin requirements which at time of recruitment are > 0.50 units/Kg together with an HbA1c value > 7.2 %; Patients with diabetes duration > 3 months who never experienced a honeymoon period as reflected by consistent HbA1c values > 7.2 % from the time of diagnosis and at the time of recruitment are using an insulin dose > 0.50 units/Kg.
  • The presence of one or more of the TRPV1 alleles similar to those found in patients currently enrolled in the TRPV1-North American - European Study.
  • Stimulated C-Peptide (measured at mixed meal tolerance at Stage A and Stage B of sP trial) ≥ 200 pmol/L and less than or equal to 1500 pmol/L.

Exclusion Criteria:

  • Patients with known co-morbidities, including ACE-inhibitor treated hypertension as well as chromosomal abnormalities, involving one or more organ systems.
  • Type 2 Diabetes Mellitus
  • Patients with a known radiographic contrast allergy
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02820558

Contacts
Contact: Holly Tschirhart 416-813-7654 ext 204517 holly.tschirhart@sickkids.ca
Contact: Catherine Pastor 416-813-7654 ext 204396

Locations
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Holly Tschirhart    416-813-7654 ext 204517    holly.tschirhart@sickkids.ca   
Contact: Catherine Pastor    416-813-7654 ext 204396    catherine.pastor@sickkids.ca   
Sponsors and Collaborators
Vanilloid Genetics Inc.
Investigators
Principal Investigator: Etienne Sochett, MD Hospital for Sick Children, Toronto Ontario
  More Information

Additional Information:
Responsible Party: Vanilloid Genetics Inc.
ClinicalTrials.gov Identifier: NCT02820558     History of Changes
Other Study ID Numbers: VanilloidGenetics-001-13
Study First Received: May 19, 2016
Last Updated: June 28, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Vanilloid Genetics Inc.:
Neuropeptide
Therapy
Onset

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Substance P
Neurokinin A
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017