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

NCT02124486 | Unknown DMC

• 4 other identifiers: RG_12-089CS-011-02814/WM/0011ISRCTN40152829
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension

Keywords

IIH; Weight loss; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Intracranial Pressure

  Change in Intracranial Pressure (ICP) between baseline and 12 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.

  12 months

Secondary Outcomes (9)

• Intracranial Pressure

  60 months

• IIH symptoms

  12 months

• Visual function

  12 months

• Papilloedema

  12 months

• Headache

  12 months

Other Outcomes (3)

• Biomarkers

  12 months

• Matched control group comparison

  Baseline

• MRI Test Run

  Baseline

Study Arms (4)

Dietetic Intervention

ACTIVE COMPARATOR

Participants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers diet programme.

Behavioral: Dietetic intervention

Bariatric surgery

EXPERIMENTAL

Patients randomised to the bariatric surgery arm will be referred to the bariatric surgery pathway and, if judged suitable according to the bariatric surgery clinic's screening processes, undergo bariatric surgery.

Procedure: Bariatric surgery

Matched obese control group

NO INTERVENTION

To evaluate the baseline difference in ICP between IIH patients and a matched obese control cohort we will recruit 20 obese but otherwise healthy participants who will undergo the same baseline visit as the main trial participants and then exit the study.

MRI Test run

NO INTERVENTION

5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial.

Interventions

Bariatric surgery PROCEDURE

Participants randomised to the bariatric surgery arm of the trial will be referred to the surgery pathway according to NICE guidelines at Birmingham Heartlands Hospital (BHH), Heart of England NHS Foundation Trust.

Bariatric surgery

Dietetic intervention BEHAVIORAL

Participants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers.

Also known as: Weight Watchers

Dietetic Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Definite indication for or contraindication against surgery or dieting.
• 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).
• Previous bariatric surgery.
• Taken AZD4017 within the last four months .
• Inability to give informed consent e.g. due to cognitive impairment.

Sponsors & Collaborators

• University of Birmingham: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University Hospital Birmingham (Queen Elizabeth Hospital)

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (6)

• Grech O, Seneviratne SY, Alimajstorovic Z, Yiangou A, Mitchell JL, Smith TB, Mollan SP, Lavery GG, Ludwig C, Sinclair AJ. Nuclear Magnetic Resonance Spectroscopy Metabolomics in Idiopathic Intracranial Hypertension to Identify Markers of Disease and Headache. Neurology. 2022 Oct 17;99(16):e1702-e1714. doi: 10.1212/WNL.0000000000201007.

  PMID: 36240084 DERIVED

• 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.

  PMID: 35790425 DERIVED

• 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.

  PMID: 34620087 DERIVED

• 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.

  PMID: 34420064 DERIVED

• 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.

  PMID: 33900360 DERIVED

• 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.

  PMID: 28963303 DERIVED

MeSH Terms

Conditions

Pseudotumor Cerebri; Weight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Alexandra Sinclair, MBChB

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Clinician Scientist and Honorary Consultant Neurologist

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 28, 2014
• Study Start: March 6, 2014
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2022
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

GB (1)