Immune response in T1D

Recruiting to: ongoing

Summary

We are inviting people with and without T1D to identify the immune mechanisms that are driven by genome variations that are associated with protection from T1D development in people with and without other diabetes genetic risk factors. We will explore people’s immune cells to see how functional those cells are, and whether there are differences in their phenotype in individuals that have protective genes compared to those that have gene variations that suggest increased risk to T1D development.

Contact us
Call: 020 7594 3735

Email: m.dominguez-villar@imperial.ac.uk

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T1D Stigma

Recruiting to: September 2025

Aim

We know that some people with diabetes can experience feelings of disapproval and judgement against them as a result of their condition, which is described as a feeling stigmatised or experiencing stigma and that this can be distressing. We would like to assess how this affects a wide range of people with the condition, in order to understand who is more likely to be affected, how it can affect them and why they feel this way. The results of the study will identify ways we can reduce the effect of stigma on people living with diabetes, as well as ways to intervene in society to prevent it.

Contact us

Call: 020 7594 5307, Harriet Housby, Research Assistant

Email: t1dstigmastudy@ic.ac.uk

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Alpha MSH

Recruiting to: December 2024

Summary

In the study we are infusing the natural hormone alpha-melanocyte stimulatory hormone (alpha-MSH) to find out if it causes a reduction in blood sugar levels. The hormone infusion is safe, with only flushing of the face reported by some people.

Aim

What is involved?

Attending a screening visit at Hammersmith Hospital at which blood samples will be taken, followed by 2 study visits of 4 hours, at least 48 hours apart. The main study visits will include receiving an infusion of either the treatment being studied or a placebo, followed by a glucose tolerance test to see how the treatment has affected your blood sugar levels. Several blood samples will be taken over the course of the screening visits and you will be asked questions about your response.

Contact us
Email: brett.johnson@nhs.net

Call: 07592589553

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Full Study title: Study Investigating the effects of Alpha-melanocyte stimulatory hormone (alpha-MSH) on reducing blood sugar levels

Eligibility to take part

Inclusion Criteria

18-50 years age
Type 1 diabetes with low/undetectable c-peptide
BMI 18-30

What will I be asked to do?
Screening will be performed to confirm that patients meet the inclusion criteria for the study. During this session, the purpose of this study will be fully explained. All questions will be answered, and consent obtained before any procedures are performed. The screening visit will include:

Informed consent
Medical history and physical examination
Measurement of height and weight
Measurement of vital signs (blood pressure, heart rate)
Electrocardiogram (ECG)
Blood sampling (including full blood count, urea and electrolytes, liver function tests, glucose, C-peptide, thyroid function test, HbA1c). Samples will be assayed in the clinical laboratories at Imperial College Healthcare NHS Trust.
Pregnancy test for females. If positive, they will be excluded from the study. • Bio-electrical impedance analysis to calculate body composition

Participants will be asked to refrain from alcohol and strenuous physical activity for 48 hours before the study. They will also be asked to consume a standardised meal the evening before the study and only consume fluids from 10pm onwards. Participants will attend the Imperial NIHR clinical research facility on the day of the visit. Two venous catheters will be inserted. The first cannula will be used for infusions and the other for blood sampling. Female participants will be studied in the follicular stage of their menstrual cycle.

The sequence of work-up of each study visit will be as per below:

Pregnancy test for females. If positive, they will be excluded from the study.
Anthropometric Measurements (height, weight, body composition using bioimpedance)
Record medications and any changes in health
Cannulation
Infusion of study solution (α-MSH at one of three concentrations or saline)
Oral Glucose Tolerance Test (OGTT)
Visual analogue scale for nausea, malaise and facial flushing during the infusion

The saline visit will involve infusion of pharmaceutical GMP-grade sterile 0.5% human albumin (dissolved in saline) obtained from Imperial College Healthcare NHS Trust. Peptides solutions will be made up with 0.5% human albumin dissolved in saline. To reduce binding of peptides to infusion lines, 0.5% human albumin dissolved in saline will be used to prime the infusion lines prior to infusion of the peptides or placebo solutions. α-MSH will be dissolved in 0.9% saline containing 0.5% human albumin to reduce adsorption to the syringe and tubing. The participants will be cannulated then allowed to rest for 30 minutes, after which they will receive an infusion of either saline or α-MSH. Thirty minutes after the infusion has started patients will undergo a standard oral glucose tolerance test: they will be asked to consume a liquid containing 75g glucose within 5 minutes. After the 210 minute infusion has ceased, the participants will remained cannulated for an additional 30 minutes where a final sample will be drawn, and the participant discharged. Blood samples will be collected, and visual analogue scales recorded at the following time points relative to initiation of infusion: -30, 0, 15, 30, 60, 90, 120, 150, 180 minutes.

Who is running this study?
The study is sponsored by Imperial College London and funded by the Obesity Research Fund. The Chief Investigator is Professor Alex Miras

Study location

Hammersmith Hospital

ELSA – EARLY SURVEILLANCE FOR AUTOIMMUNE DIABETES

Recruiting to: ongoing

‘Sooner we screen, sooner we can intervene’

Aim

The ELSA Study is screening children aged from 3-13 years to determine their risk of developing type 1 diabetes.

Who can take part?

ANY child aged 3-13 years who does not currently have type 1 diabetes. There is no need for the child to be from a family where someone has type 1 diabetes – children from any family can be tested.

What does the ELSA study involve?
Parents/guardians willing for their child/ren to take part in the ELSA Study can complete the consent form online or by post. The screening test is a simple finger-stick blood test. The home testing kit is available to families across the United Kingdom and this will be sent by post with instructions and a video of how to perform the test.

For any child found to be at risk of type 1 diabetes in the future, we will invite the family to attend a one-to-one education session to explain what the results mean. We will also refer the family to further research studies their child may be eligible for, including monitoring follow-up and prevention trials.

For more information, please visit our online information tool for parents: https://elsa-info.digitrial.com/get-started

For any queries, please contact the ELSA Study Team:

Online contact form: https://elsadiabetes.nhs.uk/contact-us/

Call: 0121 414 7814 (Monday – Friday, 9-5pm)

Email: elsa@contacts.bham.ac.uk

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Who is running this study?
The ELSA study is being run by the University of Birmingham and led by Professor Parth Narendran. The ELSA study is co-funded by Diabetes UK and JDRF.

Recruiting sites

Recruiting nationally via online and postal systems to all eligible families in the UK.
Open to recruitment:

Birmingham Children’s Hospital
Birmingham Community Healthcare Trust
University Hospitals Sussex NHS
Cambridge Addenbrooks Hospital
Royal Devon and Exeter Hospital, Exeter
East Lancashire Royal Blackburn Hospital
Leeds Children’s Hospital
Alder Hey Children’s Hospital
Barts Health NHS Trust
Royal Free Hospital, London
Newcastle Royal Victoria Infirmary
Nottingham Queen’s Medical Centre
Oxford University Hospital
University Hospital Southampton
Surrey and Sussex Healthcare NHS Trust
Royal Aberdeen Children’s Hospital
NHS Tayside
West Glasgow Ambulatory Care Hospital
Southern Health and Social Care Trust

Opening soon

Royal Infirmary of Edinburgh

What will I be asked to do?

In the ELSA Study, we are screening children for type 1 diabetes. The study has 5 steps:

Step 1 – Finger prick blood test to screen for antibodies (20,000 children)
Step 2 – Venous blood test to test for antibodies (for children who screened positive at stage 1)
Step 3 – Venous blood tests for staging of type 1 diabetes (for children who tested positive at stage 2)
Step 4 – Education session (for parents of children at-risk)
Step 5 – Interviews with parents/guardians to provide feedback on the screening programme

What are we testing for?
In the ELSA study, we are testing for antibodies (protein markers in the blood) because antibodies are markers of risk of type 1 diabetes. There are 4 antibodies we are testing for in the ELSA Study.

As the number of antibodies a child has rises, this increases their risk of developing type 1 diabetes in the future. For example, for children who have 2 of these antibodies, within the next 10 years, 3 in 4 of these children will develop symptoms of type 1 diabetes.

For children who have 1 of these antibodies present, their risk is not as high, but they could develop more antibodies over time.
For children who do not have any of these antibodies, this means they are currently at low risk of developing type 1 diabetes. But, they could still develop antibodies in the future

3 in 1000 children are at high risk of getting type 1 diabetes and we can only find these children by screening.

DIABETIC TWIN STUDY

Currently Recruiting

Aim: To study the influence of environment and genes on the onset of type 1 diabetes using identical twins.

What will taking part involve?

You will be asked to give a blood sample and a mouth swab sample, and you will be asked about your health

Contact the study directly:

Call: 020 7882 2365 Dr Mohammed Hawa, Study Manager
Email: m.i.hawa@qmul.ac.uk

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