Aim: Verapamil, a known blood pressure lowering drug, has been shown recently to protect and strengthen beta cells and slows down beta cell destruction in Type 1 diabetes. The aim is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg).
What will taking part involve?
Those who take part will be asked to attend a study visit for screening, then take a tablet once a day for 1 year which will either be Verapamil or a placebo. There will be seven treatment visits and three phone visits during this time with different tests taken, and an optional follow up visit at 2 years.
A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-A- T1D)
Eligibility to take part
Age 18-45
Diagnosed with type 1 diabetes in the last 6 weeks
What will I be asked to do?
After signing the informed consent, you will be asked to come in for a screening visit to check if you are eligible for the study. If you are eligible, you will attend for a randomisation visit where it will be decided by chance which study medication you will receive (active or dummy). This is followed by 7 treatment visits (at the clinic), accompanied by 3 phone calls (phone visits). The amount of time you will spend at the clinic at each visit may vary. This is because the tests and checks will differ at each visit.
Study locations
Southmead Hospital, Bristol.
Queen Elizabeth Hospital, Birmingham.
Addenbrookes Hospital Cambridge,
University Hospital of Wales, Cardiff,
Guy’s Hospital (KCL), London,
Bart’s Hospital (QMUL), London,
Queen’s Medical Centre, Nottingham,
OCDEM, John Radcliffe Hospital, Oxford,
Royal Hallamshire Hospital, Sheffield,
Singleton Hospital, Swansea.
Who is running this study?
Study Sponsor: Medical University of Graz Department of Internal Medicine, Austria
Chief Investigator: Prof. Thomas Pieber, MD (Medical University of Graz, Austria)
Co-Chief Investigator: Prof. Colin Dayan, MD (Cardiff University School of Medicine, UK)
MELD-ATG
Currently recruiting
Aim People develop Type 1 diabetes (T1D) because their immune system, the part of the body which helps fight infections, mistakenly attacks and destroys the insulin-producing cells in the pancreas (beta cells). When the immune system destroys these cells, the body’s ability to produce insulin decreases, blood glucose levels run high, and T1D develops.
At the time of diagnosis of T1D, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. We call this level of activity “beta cell function”. Most people with T1D will eventually stop producing insulin themselves. This may occur rapidly in a few months, or more slowly over several years. However, the longer people with T1D can produce their own insulin, the better it is for the control of blood glucose levels and to avoid long-term complications.
Previous research has shown that a drug called anti-thymocyte globulin (ATG) may help prevent the immune system from attacking and destroying the insulin-producing beta cells. In the MELD-ATG trial, we are looking for the minimum effective low doseofATG in young people newly diagnosed with T1D that:
Can slow the decline of beta cell function and preserve the body’s own insulin production
Has manageable side effects
What Will Taking Part Involve?
Participation will involve 8-10 hospital/clinic visits over about 13 months, and some at-home collections. Most visits take 1-4 hours. Treatment is given over two consecutive days and includes one overnight stay for most participants.
Full Study title Phase II, dose ranging, efficacy study of anti-thymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes (T1D)
Eligibility to take part 1. Be aged ≥5 years to ≤25 years at time of written informed consent/assent
(NOTE: Currently recruiting 12-25yrs. Recruitment will open to lower age range following safety review of first 10 participants aged 12-17 who have received an active dose of ATG).
2. Have been diagnosed with T1D within 3–9 weeks of planned treatment day 1
What will I be asked to do? (in detail)
Screening visit (duration 2 hours)
After signing the Consent Form, you will be invited for a screening visit to see if you are eligible for the trial. We will ask about your diabetes diagnosis, medical history, and recent medications and vaccinations. You will have blood samples taken which include tests to check you are fit and well, and to screen for T1D related auto-antibodies and c-peptide levels.
Baseline visit (duration 4 hours) – fasted
If you are eligible to take part, you will have a baseline visit no more than 3 weeks after the screening visit. We will do a number of assessments including height/weight, a physical exam, blood pressure, heart rate, temperature/respiratory rate, review of any recent changes in health and medications and a mixed meal tolerance test (MMTT).
Treatment visit (duration 2 days)
If you are fit and well, you will have a treatment visit no more than 9 weeks from T1D diagnosis. Most participants will need an overnight stay for this visit, as there is no gap between treatment days 1 and 2. You will be able to eat and drink and give your insulin, as normal.
Treatment will be assigned in a random way (by chance), much like flipping a coin, by a central computer programme. This treatment will be either:
Active drug (a low dose of ATG)
Placebo (dummy drug)
Neither you nor your research team will know which treatment you are given but overall 3 out of 4 people will get the active treatment.
Treatment day 1
A nurse or doctor will talk to you about your health.
An intravenous cannula will be inserted, through which your trial treatment will be given
Pre-treatment medications (an antihistamine, an anti-inflammatory and paracetamol) will be given. Some are given orally and others through the cannula. These medications are a precaution because some people can react to the trial treatment (see section 1.12, for possible side effects)
Trial treatment infusion will take at least 12 hours
Blood samples will be collected
Vital signs (blood pressure, heart rate, oxygen saturation, respiratory rate, and temperature) will be checked throughout.
Treatment day 2
You will start your second trial treatment infusion at least 12 hours after completing the first. With the exception of the trial infusion which will only last 8 hrs, day 2 is the same as day 1, including pre-treatment medications, collecting blood samples, and measuring vital signs. Where possible, your intravenous cannula will be kept in place and used again on day 2. You will be able to go home after the infusion, once your research team agrees you are fit and well enough to do so.
Follow up visits
You will have 6 follow up visits at the hospital/clinic during the 12 months after finishing the trial treatment.
1 week after treatment (duration 1 hour)
2 weeks after treatment (duration 1 hour)
Your doctor or nurse will also be in contact (e.g. by phone) between the 2- and 4-week visits to discuss any changes in your health
4 weeks after treatment (duration 1 hour)
3 months after treatment (duration 4 hours) – fasted to include MMTT
6 months after treatment (duration 4 hours) – fasted to include MMTT
12 months after treatment (duration 4 hours) – fasted to include MMTT
Visits will include medical review, height/weight, vital signs, blood samples and for visit 3, 6 and 12 a MMTT
Home collection
You will also be asked to collect the following samples at home. The research team will go over these to ensure you know what to do:
Dried blood spots: Collection of dried blood spot samples (via a small finger prick) and blood glucose measurements, before and after a liquid meal (like the milkshake drink for the mixed-meal tolerance test).
Urine and stool samples: Collection of urine and stool samples at home within 1 week before or after the baseline, 3, 6- and 12-month follow up visits.
Trial diary: A short trial diary to complete at home following trial treatment. This will cover things like taking any medications and describing any possible side effects.
Continuous glucose monitoring (CGM): Use a CGM device (provided by the study) for 14 days after each of the 3-, 6- and 12-month follow up visits, to measure blood glucose levels 24 hours a day.
Who is running this study? MELD-ATG is coordinated by the University of Cambridge, UK, on behalf of the sponsor (University Hospital Leuven [UZ Leuven], Belgium).
The trial is part of a large research group called INNODIA (An innovative approach towards understanding and arresting Type 1 diabetes; www.innodia.eu). INNODIA brings together diabetes experts from across the UK and Europe, and aims to better understand the reasons why T1D develops and how it could be prevented.
MELD-ATG is funded by the Innovative Medicines Initiative 2 Joint Undertaking (grant agreement 115797). This receives support from the EU’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), Juvenile Diabetes Research Foundation and the Leona M. and Harry B. Helmsley Charitable Trust.
Alpha MSH
Recruiting to: December 2023
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
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.
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.
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
Extod-Immune
Recruiting to: March 2025
Summary
The project is for patients with type-1 diabetes (diagnosed within 3 years) who are not physically active. Patients will be asked to undertake an exercise intervention for 12 weeks in their own home, followed by a 12-week control period with no prescribed exercise.
Aim
The aim of this project is to investigate the impact of a remotely monitored exercise intervention on immune driven disease activity in patients with a recent diagnosis of type-1 diabetes vs. standard care with no prescribed exercise.
Full Study title: Can a remotely monitored, home-based exercise intervention for individuals with type-one diabetes reduce immune-driven disease activity?
Eligibility to take part
Inclusion Criteria
Age: 18-60 years old
Clinical diagnosis of T1D made within the past 3 years.
Self‐administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
Both participant and physician feel that they are able to exercise safely.
Patient is able to estimate carbohydrate content of meals
Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L
Exclusion Criteria
Uncontrolled blood pressure
Pregnancy or planning pregnancy
Adhering to the current recommended physical activity guidelines (> 150 minutes)
Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion.
Unable to provide full informed consent.
What will I be asked to do? If you agree to take part in the study and meet the inclusion criteria after our initial screening (conducted remotely, including a saliva sample), you will be invited to attend your local Clinical Research Facility (CRF) on four separate occasions over a 36-week period. On each visit, we will carry out a medical review and measure your weight, blood pressure, pulse and draw a blood sample. We will also ask you to wear a flash glucose monitor for 2 weeks. You will then be
You will then be randomly allocated to either a home-based exercise or control group (undertake your usual level of exercise without any extra support from us) between weeks 1-12. Following a 12-week break from the study, you will be allocated to the other group in weeks 24-36. Please see a simplified study schematic below:
The exercise is safe for people with type-1 diabetes to undertake at home. Details are outlined below:
For weeks 1-2 of the intervention, we will ask participants to:
Perform a low intensity warm up for 2-minutes
Perform 6 x 1-minute high intensity intervals (bodyweight exercises), interspersed with 1-minute rest intervals (11 minutes). You will be asked to exercise at an intensity that elicits 80% of your maximum heart rate.
Total exercise time will be 13 minutes.
For weeks 3-4 of the intervention, this will increase to 8 intervals (total exercise time will be 17 minutes).
For weeks 5-12 of the intervention, this will increase to 10 intervals (total exercise time will be 21 minutes).
Reimbursement
Participants will receive a £50 Amazon voucher upon completion of the study. Travel expenses incurred by site visits may also be reimbursed.
Who is running this study? Sponsor: University of Birmingham,
Chief Investigator: Dr Alex Wadley
Funder: The Rosetrees Trust
Study Location
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Musgrove Park Hospital, Somerset NHS Foundation Trust
School of Sport and Exercise Sciences, Liverpool John Moors University
Royal Free Hospital, Royal Free London NHS Foundation Trust
ELSA – EARLY SURVEILLANCE FOR AUTOIMMUNE DIABETES
Recruiting until: End of August 2024
‘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:
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.
For an up to date list of sites, please visit www.elsadiabetes.nhs.uk/study-sites
What will I be asked to do? (in detail)
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.
