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

University of Birmingham

Status: Unknown

Conditions: Idiopathic Intracranial Hypertension

Treatments: Behavioral: Dietetic intervention; Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02124486

14/WM/0011 (Other Identifier)

CS-011-028 (Other Grant/Funding Number)

RG_12-089

ISRCTN40152829 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 4 patient groups

Dietetic Intervention

Active Comparator group

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.

Treatment:

Behavioral: Dietetic intervention

Bariatric surgery

Experimental group

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.

Treatment:

Procedure: Bariatric surgery

Matched obese control group

No Intervention group

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.

MRI Test run

No Intervention group

Description:

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