Immune Profile in Subjects With New Onset Type 1 Diabetes

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 25, 2016

Primary Completion Date

December 21, 2017

Study Completion Date

December 21, 2017

Conditions
Diabetes Mellitus, Type 1
Interventions
PROCEDURE

Inguinal lymph node fine needle aspirate biopsy

Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.

PROCEDURE

Inguinal lymph node core biopsy

Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.

PROCEDURE

Peripheral blood collection

Blood sample (30 mL) will be collected, to derive immune cells.

OTHER

Pre- and post-biopsy questionnaire

All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.

Trial Locations (2)

CB2 0QQ

GSK Investigational Site, Cambridge

CF14 4XN

GSK Investigational Site, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY