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
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intracranial Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Dietetic intervention (Behavioral)
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.
干预措施: Bariatric surgery (Procedure)
MRI Test run
5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial.
结局指标
主要结局
Intracranial Pressure
时间窗: 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.
次要结局
- Quality of Life (EQ-5D-5L and SF-36)(12 months)
- Intracranial Pressure(60 months)
- Anthropometric measures(12 months)
- Headache(12 months)
- Papilloedema(12 months)
- IIH symptoms(12 months)
- Visual function(12 months)
- Referrals to CSF shunting procedures and optic nerve sheath fenestration(12 months)
- Health Economics(12 months)
研究者
Dr Alexandra Sinclair
NIHR Clinician Scientist and Honorary Consultant Neurologist
University of Birmingham