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Clinical trial summary
We are conducting a clinical trial in patients with type 2 diabetes. In this clinical trial, we are recruiting women and men aged 18 to 64 with type 2 diabetes. We will look at the effect of high blood sugar in combination with a commonly used antibiotic on the heart. You will be paid for your time and commitment if you take part in this clinical trial.
- You will need to attend a screening appointment to see if you are suitable to take part in the trial. At this appointment, you will have blood tests done, we will check your heart and carry out a brief physical examination.
- If results from your screening appointment show you are suitable for the trial: You will be invited to attend a pre-treatment visit where you will be fitted with a glucose monitor and instructed to stop taking your current diabetic medication (if taking any) prior to admission. After this visit, you will be asked to attend the clinical research unit for a single in-house stay of 5 days / 4 nights.
- During your stay with us, you will receive a glucose (sugar) solution and an antibiotic or placebo (a product that looks like the drug but does not contain an active ingredient) via your blood vessels. We will conduct a number of assessments (like those done at screening) to check how your heart responds to increased sugar levels in combination with the antibiotic.
- After your stay with us, you will be required to return for one further outpatient appointment.
- In total, you will be required to visit the research unit 4 times if you are included in the trial. However, the whole process takes approximately 45 days, from your screening visit through to your final visit at the end of the trial.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- Your Body Mass Index (BMI) must be between 18.0 - 40.0 kg/m² (inclusive).
- Your blood sugar must be controlled with either: diet and exercise alone or, diabetic medication (but not any form of insulin).
- You must be able to stop taking your current diabetic medication (if taking any), to allow it to fully leave your system, prior to admission into the unit.
- You must not have type 2 diabetes-related complications.
- You must not consume tobacco in any form or other nicotine-containing products 3 months before your admission and during the clinical trial.
- You must not show any evidence of drug or alcohol abuse in the last 5 years. (Alcohol abuse is defined as a regular weekly intake of more than 14 units).
- You must not have been hospitalised due to low or high blood sugar within one month before the screening visit.
- You must not be pregnant or breastfeeding.
- Female volunteers of childbearing potential must agree to the use of highly effective contraception starting one menstrual cycle prior to starting the trial.
- Male volunteers must be willing to use appropriate contraception, but we will discuss this with you at your screening visit.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive up to £1,000 (£700 clinical trial payment and £300 bonus for compliance) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits. Please note that the clinical trial payment includes travel expenses.
Clinical trial dates
You will be selected to participate in only one of the cohorts below:
Cohort 16 admission: 12th December
Dismissal: 16th December
Follow-up visit(s): 22nd December
Cohort 17 admission: 19th December
Dismissal: 23rd December
Follow-up visit(s): 29th December
More cohorts will be added at a later date.
Approval
The contents of this email have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C20032_Feb_2023 (email_website_advert text)
