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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Trial of Bariatric Surgery Versus a Community Weight Loss Programme for the Sustained Treatment of Idiopathic Intracranial Hypertension: the IIH:WT

Brief 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 obes

Detailed Summary:
Sponsor: University of Birmingham

Current Primary Outcome: Intracranial Pressure [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Intracranial Pressure [ Time Frame: 60 months ]

  Change in ICP between baseline and 24 and 60 months.

  ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.

• IIH symptoms [ Time Frame: 12 months ]
  Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months)
• Visual function [ Time Frame: 12 months ]

  Change in visual function from 0 to 12 months (and at 24 and 60 months).

  Assessments to be undertaken are the LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation, an evaluation of contrast sensitivity and an Ishihara book to assess colour vision. The pupils will then be dilated using 1% tropicamide. Papilloedema will then be measured using spectral optical coherence tomography. Papilloedema will be further graded following fundus photographs. This will be done after all participants have reached the primary endpoint by two neuro-ophthalmologists blinded to trial treatment arm. The assessors will score the paired papilloedema images as better/same/worse as per the methodology described in a previous study. They will also assign a Frisen score to the images.

• Papilloedema [ Time Frame: 12 months ]
  Change in papilloedema from 0 to 12 months (and at 24 and 60 months)
• Headache [ Time Frame: 12 months ]

  Change in headache associated disability from 0 to 12 months (and at 24 and 60 months).

  Headache will be assessed by participant completed questionnaires. Participants will complete a daily headache diary in the week before assessments, which will evaluate the Headache Index score and use of analgesia (days/week). Headache associated disability will be evaluated using the Headache Impact Test-6 score (HIT 6). Severity and frequency of headaches will be assessed retrospectively using the Headache Index. Headache phenotype (according to criteria from the International Headache Society) will also be assessed.

• Anthropological measures [ Time Frame: 12 months ]
  Change in anthropological measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months)
• Quality of Life [ Time Frame: 12 months ]
  Change in quality of life (participant reported) from 0 to 12 months (and at 24 and 60 months)
• Referrals to CSF shunting procedures and optic nerve sheath fenestration [ Time Frame: 12 months ]
  Difference in number of referrals to cerebrospinal fluid (CSF) shunting procedures and optic nerve sheath fenestration between treatment arms at 0 to 12 months (and at 24 and 60 months)
• Health Economics [ Time Frame: 12 months ]
  Health economics including cost-effectiveness at 12, 24 and 60 months.

Original Secondary Outcome: Same as current

Information By: University of Birmingham

Dates:
Date Received: April 22, 2014
Date Started: March 2014
Date Completion: October 2022
Last Updated: April 25, 2017
Last Verified: April 2017