UnknownNot Applicable

An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH

United Kingdom90 participantsStarted 2014-03-06

Plain-language summary

Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes. The condition is associated with raised pressure in the brain and can cause disabling daily headaches and loss of sight, 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. Weight loss is difficult to maintain. This trial 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 sustainable treatment for IIH. Bariatric surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery. This trial will recruit 64 women with IIH from Neurology and Ophthalmology clinics in UK NHS Trusts. They will be randomised and 32 participants will be allocated to the dietetic intervention arm, and be enrolled in their local Weight Watchers group. 32 participants will be allocated to the bariatric surgery arm, and will be referred to their local bariatric surgery pathway to receive bariatric surgery. Both groups of participants will be allocated to a treatment arm which is proven to bring about weight loss. Participants will then be followed up for five years, with the most important measurement being their brain pressure after one year of being in the trial. A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline symptoms and biomarkers of those with IIH; they will take no further part in the study. 5 further healthy individuals will be scanned twice in an MRI test group to validate the MRI scan sequence to be used in the trial.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (\> 6 months duration), active disease (papilloedema \[Frisen grade ≥ 1\], significantly raised ICP \> 25cmH2O) and no evidence of venous sinus thrombosis (magnetic resonance or CT imaging and venography as noted at diagnosis).
✓. BMI \>35kg/m2.
✓. Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
✓. Able to give informed consent.

Exclusion criteria

✕. Age less than 18 or older than 55 years.
✕. Pregnant or planning to conceive during the first 18 months of the trial .
✕. Significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
✕. Undergone optic nerve sheath fenestration.

What they're measuring

Intracranial Pressure

Timeframe: 12 months

Trial details

NCT IDNCT02124486

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-02

View on ClinicalTrials.gov More Idiopathic Intracranial Hypertension trials