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

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bariatric surgery
Dietetic intervention
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring IIH, Weight loss, Bariatric surgery

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital Birmingham (Queen Elizabeth Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

No Intervention

No Intervention

Arm Label

Dietetic Intervention

Bariatric surgery

Matched obese control group

MRI Test run

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intracranial Pressure
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
Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months)
Visual function
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
Change in papilloedema from 0 to 12 months (and at 24 and 60 months)
Headache
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.
Anthropometric measures
Change in anthropometric measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months)
Quality of Life (EQ-5D-5L and SF-36)
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
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
Health economics including cost-effectiveness at 12, 24 and 60 months.

Full Information

First Posted
April 22, 2014
Last Updated
November 3, 2020
Sponsor
University of Birmingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02124486
Brief Title
An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH
Acronym
IIH:WT
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2014 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
IIH, Weight loss, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietetic Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bariatric surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched obese control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
MRI Test run
Arm Type
No Intervention
Arm Description
5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietetic intervention
Other Intervention Name(s)
Weight Watchers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intracranial Pressure
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intracranial Pressure
Description
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.
Time Frame
60 months
Title
IIH symptoms
Description
Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months)
Time Frame
12 months
Title
Visual function
Description
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.
Time Frame
12 months
Title
Papilloedema
Description
Change in papilloedema from 0 to 12 months (and at 24 and 60 months)
Time Frame
12 months
Title
Headache
Description
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.
Time Frame
12 months
Title
Anthropometric measures
Description
Change in anthropometric measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months)
Time Frame
12 months
Title
Quality of Life (EQ-5D-5L and SF-36)
Description
Change in quality of life (participant reported) from 0 to 12 months (and at 24 and 60 months)
Time Frame
12 months
Title
Referrals to CSF shunting procedures and optic nerve sheath fenestration
Description
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)
Time Frame
12 months
Title
Health Economics
Description
Health economics including cost-effectiveness at 12, 24 and 60 months.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
Change in biomarkers from 0 to 12 (and 24 and 60) months
Time Frame
12 months
Title
Matched control group comparison
Description
Comparison between IIH patients and the matched control group at baseline with respect to biomarkers and ICP.
Time Frame
Baseline
Title
MRI Test Run
Description
Change in MR imaging over a double baseline period of healthy controls.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Sinclair, MBChB
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Birmingham (Queen Elizabeth Hospital)
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35790425
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.
Results Reference
derived
PubMed Identifier
34620087
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.
Results Reference
derived
PubMed Identifier
34420064
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.
Results Reference
derived
PubMed Identifier
33900360
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. Erratum In: JAMA Neurol. 2021 Jul 1;78(7):882.
Results Reference
derived
PubMed Identifier
28963303
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.
Results Reference
derived

Learn more about this trial

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

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