BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment

Official title

Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study

Overview

1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments. 2. To establish the BMI at which this disease occurs. 3. To establish how much the BMI must be reduced to cure this disease. 4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion

Detailed description

There is unanimity that one of the causes of benign intracranial hypertension is obesity. However, there is no agreement on the upper limit of BMI above which this disease occurs or the lower limit above which it is cured. People affected by this disease often have extreme difficulty losing weight and it is not uncommon for them to have followed various diets over the years to lose weight. In general, patients prefer to take medication or to undergo surgery with the implantation of a cerebrospinal fluid diversion system that does not force them to sacrifice following a strict diet. Unfortunately, those who do not manage to lose weight noticeably present repeated complications due to malfunction of the CSF diversion system with headaches and a progressive loss of visual acuity. Among other reasons, it must be considered that cerebrospinal fluid diversion systems work by pressure gradient. Since obesity increases the pressure inside the peritoneal cavity, these shunt systems will be ineffective because they will not be able to drain even if the pressure of the shunt valve is diminished to levels below 6 mm Hg.

The aim of this study is to find out what the specific BMI goal should be for each patient in particular and to be able to make them aware of this so that they make an effort and achieve it. Patients are referred to Endocrinology to be recommended the diet to follow. In some cases, bariatric surgery is used. Still, as it does not require effort or awareness on the part of these people, it is not uncommon for them to gain weight again and for benign intracranial hypertension to recur. The usual thing is that their evolution is torpid and the repeated therapeutic attempts are fruitless or plagued by complications. Weight loss using medication such as Ozempic (Semaglutide) is not accepted internationally nor contemplated by the Endocrinology Service of the General University Hospital of Valencia. On the one hand, it has no indication and on the other hand, the possible complications are not known. In addition, patients who take it on their own initially lose weight, but when they stop taking the medication they quickly regain the lost weight as a result of not having adopted healthy eating habits.

Interventions

• Other Weight loss without pharmacotherapy
  The study will record the weight of the patients with Idiopathic Intracranial Hypertension every three months. It will correlate with the response to the different treatment modalities (weight loss with no other intervention, diuretic drugs (acetazolamide), lumboperitoneal shunt, or ventriculoperitoneal shunt). No medication will be provided to help lose weight.

Primary outcome measures

• Response to treatment [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

• Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges.
• A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria.
• The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases.

Exclusion criteria

• A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH.
• The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Spain · 1 center

• Consorcio Hospital General Universitario de Valencia — Valencia

Publications

• Kleinschmidt JJ, Digre KB, Hanover R. Idiopathic intracranial hypertension: relationship to depression, anxiety, and quality of life. Neurology. 2000 Jan 25;54(2):319-24. doi: 10.1212/wnl.54.2.319. PMID 10668690
• 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. PMID 35790425
• Ko MW, Chang SC, Ridha MA, Ney JJ, Ali TF, Friedman DI, Mejico LJ, Volpe NJ, Galetta SL, Balcer LJ, Liu GT. Weight gain and recurrence in idiopathic intracranial hypertension: a case-control study. Neurology. 2011 May 3;76(18):1564-7. doi: 10.1212/WNL.0b013e3182190f51. PMID 21536635
• Aguiar M, Frew E, Mollan SP, Mitchell JL, Ottridge RS, Alimajstorovic Z, Yiangou A, Singhal R, Tahrani AA, Sinclair AJ. The Health Economic Evaluation of Bariatric Surgery Versus a Community Weight Management Intervention Analysis from the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT). Life (Basel). 2021 Apr 30;11(5):409. doi: 10.3390/life11050409. PMID 33946177
• Elliot L, Frew E, Mollan SP, Mitchell JL, Yiangou A, Alimajstorovic Z, Ottridge RS, Wakerley BR, Thaller M, Grech O, Singhal R, Tahrani AA, Harrison M, Sinclair AJ, Aguiar M. Cost-effectiveness of bariatric surgery versus community weight management to treat obesity-related idiopathic intracranial hypertension: evidence from a single-payer healthcare system. Surg Obes Relat Dis. 2021 Jul;17(7):131 PMID 33952427
• Mahendran V, Ricart P, Levine F, White E, Abolghasemi-Malekabadi K, Williams M, Wadley MS, Perry A, Robinson SJ. Bariatric Surgery as a Viable Treatment for Idiopathic Intracranial Hypertension: a Case Series and Review of Literature. Obes Surg. 2021 Oct;31(10):4386-4391. doi: 10.1007/s11695-021-05587-4. Epub 2021 Jul 28. PMID 34322839
• 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 Hypertensi PMID 33900360
• Westgate CSJ, Markey K, Mitchell JL, Yiangou A, Singhal R, Stewart P, Tomlinson JW, Lavery GG, Mollan SP, Sinclair AJ. Increased systemic and adipose 11beta-HSD1 activity in idiopathic intracranial hypertension. Eur J Endocrinol. 2022 Jul 4;187(2):323-333. doi: 10.1530/EJE-22-0108. Print 2022 Aug 1. PMID 35584002

Identifiers

NCT: NCT06913712 · V 07/06/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗