The main objective of this trial is to evaluate the safety and delivery of substance (sP) when administered through a specific artery (celiac artery - provides oxygenated blood to certain organs such as the liver, stomach etc.) in young patients with type 1 diabetes. The main outcome to be measured is number of negative effects experienced by patients. This trial is recruiting in Toronto, Ontario (Canada).
The details
sP is a brain chemical that stimulates pain receptors in the body. When used in diabetes it promotes wound healing. Previous studies in animals have shown that mice with diabetes do not produce normal amounts of sP.
The aim of this trial is to determine how many doses of sP can be administered safely and how this will affect blood sugar levels, insulin levels and C-peptide levels (a protein linked with insulin levels).
Who are they looking for?
This trial will recruit 12 patients who are aged between 10-18 years and have had type 1 diabetes from 3 to 30 months. Participants must be injecting more than 0.5 units/kg of insulin per day. HbA1c (average blood glucose over 3 months) levels must be more than 7.2%.
Patients who have additional illnesses as well as diabetes, or those who have type 2 diabetes, will not be considered for this trial. Patients who are pregnant or who have an allergy to radiography (imaging technique that uses radiation e.g. X-rays) are not eligible.
How will it work
Patients will be assigned to one of four groups. All groups will receive sP through the celiac artery in one treatment. Group 1 will receive 1 nmol/kg, Group 2 will receive 5 nmol/kg, Group 3 will receive 15nmol/kg, and Group 4 will receive 45nmol/kg of sP. Participants will be followed for up to 6 months.
