An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH (IIH:WT)
Idiopathic Intracranial Hypertension
About this trial
This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring IIH, Weight loss, Bariatric surgery
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.
Sites / Locations
- University Hospital Birmingham (Queen Elizabeth Hospital)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
No Intervention
No Intervention
Dietetic Intervention
Bariatric surgery
Matched obese control group
MRI Test run
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.