PHNA study to assess the peripheral immune system in NOT1D pts
Research type
Research Study
Full title
Exploration of the peripheral immune system in subjects with New Onset T1 Diabetes (NOT1D)
IRAS ID
198414
Contact name
Colin Dayan
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
There is no drug being tested in this study.
The purpose of this study is to assess and compare the cells found in the inguinal lymph nodes in healthy volunteers and subjects with new onset type 1 diabetes. A lymph node plays an important role in the immune system, containing white blood cells to fight against infection. The inguinal lymph nodes are found in the groin.
This study aims to gain a better understanding of the processes that may lead to the immune system’s destruction of it's own insulin producing beta cells, which occurs in individuals with type 1 diabetes. New measurable indicators (biomarkers) may be identified that could potentially support the early evidence of effectiveness of study drugs in future type 1 diabetes trials.
This study will involve taking a biopsy (a sample of tissue taken from the body in order to examine it more closely) from the lymph node found in the groin area. Subject's will receive a local anaesthetic. The radiologist will use ultrasonography to mark carefully where the biopsy should be taken from. This study will also explore if any differences can be detected in blood samples from healthy volunteers and Type 1 Diabetes patients.
This study will involve up to 15 healthy volunteers and up to 15 subjects with new onset type 1 diabetes.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1064
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion