Neuropeptide Therapy of Recent Onset Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

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Substance P

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No