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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Dr Alexandra Sinclair, University of Birmingham
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Dr Alexandra Sinclair, University of Birmingham
ClinicalTrials.gov Identifier:
NCT02124486
First received: April 22, 2014
Last updated: April 25, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Idiopathic Intracranial Hypertension Procedure: Bariatric surgery Behavioral: Dietetic intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr Alexandra Sinclair, University of Birmingham:

Primary Outcome Measures:
  • Intracranial Pressure [ Time Frame: 12 months ]

    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.



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Biomarkers [ Time Frame: 12 months ]
    Change in biomarkers from 0 to 12 (and 24 and 60) months

  • Matched control group comparison [ Time Frame: Baseline ]
    Comparison between IIH patients and the matched control group at baseline with respect to biomarkers and ICP.

  • MRI Test Run [ Time Frame: Baseline ]
    Change in MR imaging over a double baseline period of healthy controls.


Estimated Enrollment: 90
Actual Study Start Date: March 2014
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietetic Intervention
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
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.
Other Name: Weight Watchers
Experimental: Bariatric surgery
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
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.
No Intervention: Matched obese control group
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.
No Intervention: MRI Test run
5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124486

Contacts
Contact: Alexandra Sinclair, MBChB +44 121 4143713 a.b.sinclair@bham.ac.uk
Contact: Ryan Ottridge +44121 415 9125 r.ottridge@bham.ac.uk

Locations
United Kingdom
University Hospital Birmingham (Queen Elizabeth Hospital) Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Alexandra Sinclair, MBChB    01214143713    a.b.sinclair@bham.ac.uk   
Contact: Keira Markey, MBChB    01214143713    k.a.markey@bham.ac.uk   
Sub-Investigator: Keira Markey, MBChB         
Principal Investigator: Alexandra Sinclair, MBChB         
Sub-Investigator: James Mitchell, MBChB         
Sponsors and Collaborators
University of Birmingham
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Alexandra Sinclair, MBChB University of Birmingham
  More Information

Responsible Party: Dr Alexandra Sinclair, NIHR Clinician Scientist and Honorary Consultant Neurologist, University of Birmingham
ClinicalTrials.gov Identifier: NCT02124486     History of Changes
Other Study ID Numbers: RG_12-089
CS-011-028 ( Other Grant/Funding Number: NIHR )
14/WM/0011 ( Other Identifier: Black Country Research Ethics Committee )
ISRCTN40152829 ( Registry Identifier: ISRCTN )
Study First Received: April 22, 2014
Last Updated: April 25, 2017

Keywords provided by Dr Alexandra Sinclair, University of Birmingham:
IIH
Weight loss
Bariatric surgery

Additional relevant MeSH terms:
Hypertension
Weight Loss
Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017