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Association of British
Clinical Diabetologists |
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ABCD
Endobarrier Studies - REVISE-Diabesity |
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Advice for patients who might be interested
in taking part in the study |
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Many thanks for
your interest in the study.
If you are a current / past patient in
the trial, please contact
piya.sengupta@nhs.net
or 0121 507 5723 with your name and query.
This study has now completed recruitment. If you are
interested in other current / planned trials,
please email
revise.diabesity@nhs.net
You may also wish to search for other
clinical trials of interest local to you, that you may
qualify for. You can search by topic e.g. diabetes, obesity,
weight and location at:
https://www.ukctg.nihr.ac.uk
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Are you interested and do you qualify for
the study? |
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Questions:
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Do you have type
2 diabetes?
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Are you
overweight or obese?
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Have you had
Liraglutide (trade name Victoza) injections for at least
6 months either now or previously?
If
YES to all 3 and you choose to join the trial and are found to qualify for
it, you will receive regular:
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Diabetes health checks including: Weight, Body mass
index, Blood pressure, Blood tests including blood
glucose (sugar), cholesterol, HbA1c (diabetes control )
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As part of this trial, 2 out of 3 participants that
qualify will undergo the Endobarrier procedure, while 1
out of 3 will have treatment consisting of a daily
liraglutide (Victoza) injection at a 1.8mg dose
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The study-related treatments/ procedures will be
provided at no cost to you
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More
questions to check if you may qualify for the study? |
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Are the
following answers YES?
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Yes |
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Is your latest HbA1c
(diabetes blood test) ≥ 7.5% or ≥ 58mmol/mol? |
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Is your latest body
mass index ≥ 35 kg/m2 (or ≥30 kg/m2 if from India/
Bangladesh/ Pakistan?) |
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Have you tried
liraglutide for at least 6 months previously? If yes,
what date did it start (and stop if relevant)?
If yes, what
is/ was the liraglutide dose - 0.6mg/ 1.2mg/ 1.8mg? |
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Is your HbA1c or
weight actively falling currently – for this you need
your latest and previous HbA1c and weights from present
with as many as you can obtain from GP/ diabetes centre/
hospital up until 1-2 years ago. |
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Are the following
answers NO?
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No |
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Do you suffer with
major intestinal problems including previous surgery to
the area? |
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Have you had previous
pancreatitis? |
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Have you had previous
problems with general anaesthetic? |
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Have you ever had a
stroke/ heart attack? |
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Are you currently
pregnant/ breastfeeding or do you have plans for this in
the next 2 years (if female)? |
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Are you on warfarin
treatment? |
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The sites at which the study procedures
and visits will take place if you are accepted onto this
trial are: City Hospital Birmingham; King’s College Hospital
London and Glasgow Royal Infirmary. The research team would
plan to see you once every 3 months but more frequently
initially so if this is too far for you to travel, this
study may not be suitable for you.
If you can tick all the boxes above or
are unsure about the answers, please contact your GP or
Diabetes Doctor/ Diabetes Nurse to find out about and obtain
written confirmation from them of:
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Previous weights, HbA1c results with
dates (especially the latest, and ones preceding this in the
last 3 months to 1 year, up to 2 years).
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Liraglutide start (and stop date if
relevant)
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Any answers to the above you are
unsure about
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If you are on any of the following
drugs, please find out what they are being given for in your
case:
aspirin/ clopidogrel/ dipyrimadole/
ibuprofen/ naproxen
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We
would be happy to provide information about the study to
your GP/ Diabetes Team if they wish to know more information
at this stage. Otherwise, with your permission, we would
hope to contact them if you qualify at a later stage. |
Please contact us if, after the above checks, you feel you
qualify and are interested in the study. One of the research
team will respond to your enquiry.
revise.diabesity@nhs.net
or 020 7188 8472
and leave your name, telephone number, email.
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We can provide a
written patient information sheet
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We can invite you
to one of our information sessions, during which you would
be able to sign a consent form if you still wish to
participate at the end of the session, though there is no
obligation
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Following that, we
may arrange a screening visit to check whether or not you
qualify for the study which would involve a detailed
questionnaire, examination, some measurements and blood
tests.
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Working to support high quality diabetes care in the
UK |
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