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Dr Alexandra Sinclair


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertension
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Bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertension

Not Recruiting

Open to: Female

Age: Adult

Taunton Exeter Birmingham Manchester Birmingham

Medical Conditions

Idiopathic Intracranial Hypertension (IIH) - neurology, neuro-ophthalmology.

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause that is associated with raised pressure in the brain and can cause disabling daily headaches and loss of vision, which can be permanent. The raised brain pressure squashes the nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90% of patients with IIH are overweight and weight loss is the most effective treatment. Other treatments for IIH have very little current evidence to support their use. This study aims to compare two methods of weight loss, bariatric surgery and the most effective dietary programme commonly available, Weight Watchers, to see which offers the most effective long-term treatment for IIH.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Mar 2014 31 Oct 2018

Publications

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28963303/ (added 22/04/2021)2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34420064/ Sub-study results (added 23/08/2021)2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35790425/ (added 06/07/2022)

Participants with IIH are randomly allocated to either attend their local Weight Watchers group or undergo bariatric surgery. The latter are referred to the Birmingham Heartlands Hospital to receive a choice of gastric banding, gastric bypass, or sleeve gastrectomy. A third control group of 20 women with similar characteristics but who do not have IIH provide a comparison but do not participate further in the study. Participants with IIH are then followed up for five years, with the most important measurement being their brain pressure after one year of being in the study. Participants with IIH and the 20 obese controls are also asked to give samples of urine, blood and cerebrospinal fluid, and are asked to participate in sub-studies which look at the relationship between IIH and other illnesses connected with obesity from which they may suffer.


Women aged between 18 and 55 with IIH and body mass index (BMI) >35kg/m2. Women who do not have IIH are also enrolled for comparison.

You can take part if:



You may not be able to take part if:


Original exclusion criteria:1. Age less than 18 or older than 55 years 2. Pregnant 3. Significant co-morbidity, endocrinopathy or the use of hormone-manipulating medication4. Undergone optic nerve sheath fenestration5. Definite indication for or contraindication against surgery or dieting6. Have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Musgrove Park Hospital
    Taunton
    TA1 5DA
  • Royal Devon and Exeter Hospital
    Barrack Road
    Exeter
    EX2 5DW
  • Heartlands Hospital
    Bordesley Green East
    Birmingham
    B9 5SS
  • Manchester Royal Eye Hospital
    Oxford Road
    Manchester
    M13 9WL
  • University Hospitals Birmingham
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW

The benefit is that both groups of participants receive a treatment which is proven to bring about weight loss. The main risk is to patients in the bariatric surgery arm: bariatric surgery, although safe, is a major operation, and careful follow-up is required. Apart from the risks of bariatric surgery for those participants in the surgery arm, the main risks are those of side effects involved in the lumbar punctures, and the discomfort of the lumbar punctures and of the blood samples being taken.

Dr Alexandra Sinclair



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Birmingham (UK) and funded by National Institute for Health Research (NIHR) (UK) - Research Fellowship, NIHR-CS-011-028.



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Read full details for Trial ID: ISRCTN40152829

Or CPMS 16025

Last updated 06 July 2022

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