Neuropeptide Therapy of Recent Onset Type 1 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Substance P.

This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Recent onset T1D (CDA 2013 guidelines: See link in links section. Age 10-18 years. Disease Duration 3-30 months. 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.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Substance P group and the comparison group ran side by side rather than switching.

Everyone knew when Substance P was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-05 with completion listed for 2022-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Stage A Safety: Side effects reported for entire cohort (time frame: Reported during the first 20-27 days following sP administration).

It also tracked 2 secondary outcomes, for example C-Peptide Levels (small cohort) and C-Peptide Levels (large cohort).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Substance P in 12 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Substance P compound page, all human trials.