Clinical trial NCT02124486: An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH
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 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Intracranial Hypertension
Keywords: IIH
Weight loss
Bariatric surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. 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).
2. BMI \>35kg/m2.
3. 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.
4. Able to give informed consent.

Exclusion Criteria:

1. Age less than 18 or older than 55 years.
2. Pregnant or planning to conceive during the first 18 months of the trial .
3. Significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
4. Undergone optic nerve sheath fenestration.
5. Definite indication for or contraindication against surgery or dieting.
6. 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).
7. Previous bariatric surgery.
8. Taken AZD4017 within the last four months .
9. Inability to give informed consent e.g. due to cognitive impairment.

Primary outcomes:
measure: Intracranial Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Intracranial Pressure
timeFrame: 60 months
measure: IIH symptoms
timeFrame: 12 months
measure: Visual function
timeFrame: 12 months
measure: Papilloedema
timeFrame: 12 months
measure: Headache
timeFrame: 12 months
measure: Anthropometric measures
timeFrame: 12 months
measure: Quality of Life (EQ-5D-5L and SF-36)
timeFrame: 12 months
measure: Referrals to CSF shunting procedures and optic nerve sheath fenestration
timeFrame: 12 months
measure: Health Economics
timeFrame: 12 months
Other outcomes:
measure: Biomarkers
timeFrame: 12 months
measure: Matched control group comparison
timeFrame: Baseline
measure: MRI Test Run
timeFrame: Baseline
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham (Queen Elizabeth Hospital)
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Alexandra Sinclair, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mollan SP, Mitchell JL, Yiangou A, Ottridge RS, Alimajstorovic Z, Cartwright DM, Hickman SJ, Markey KA, Singhal R, Tahrani AA, Frew E, Brock K, Sinclair AJ. Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension. Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
citation: Mollan SP, Wakerley BR, Alimajstorovic Z, Mitchell J, Ottridge R, Yiangou A, Thaller M, Gupta A, Grech O, Lavery G, Brock K, Sinclair AJ. Intracranial pressure directly predicts headache morbidity in idiopathic intracranial hypertension. J Headache Pain. 2021 Oct 7;22(1):118. doi: 10.1186/s10194-021-01321-8.
citation: Yiangou A, Mitchell JL, Nicholls M, Chong YJ, Vijay V, Wakerley BR, Lavery GG, Tahrani AA, Mollan SP, Sinclair AJ. Obstructive sleep apnoea in women with idiopathic intracranial hypertension: a sub-study of the idiopathic intracranial hypertension weight randomised controlled trial (IIH: WT). J Neurol. 2022 Apr;269(4):1945-1956. doi: 10.1007/s00415-021-10700-9. Epub 2021 Aug 22.
citation: Mollan SP, Mitchell JL, Ottridge RS, Aguiar M, Yiangou A, Alimajstorovic Z, Cartwright DM, Grech O, Lavery GG, Westgate CSJ, Vijay V, Scotton W, Wakerley BR, Matthews TD, Ansons A, Hickman SJ, Benzimra J, Rick C, Singhal R, Tahrani AA, Brock K, Frew E, Sinclair AJ. Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
citation: Ottridge R, Mollan SP, Botfield H, Frew E, Ives NJ, Matthews T, Mitchell J, Rick C, Singhal R, Woolley R, Sinclair AJ. Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open. 2017 Sep 27;7(9):e017426. doi: 10.1136/bmjopen-2017-017426.