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

NCT ID: NCT06913712

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2027-04-01

Brief Summary

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Patients with Idiopathic Intracranial Hypertension

Patients with Idiopathic Intracranial Hypertension

Weight loss without pharmacotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Vicente Vanaclocha

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Vicente Vanaclocha, Professor

Role: CONTACT

vivava@uv.es

+ 34 963 13 18 00 ext. 438500

Teresa Moratal, Secretary

Role: CONTACT

moratal_ter@fihguv.es

+ 34 963 13 18 00 ext. 437334

Facility Contacts

Vicente Vanaclocha, Professor

Role: primary

vivava@uv.es

+34 963 13 18 00 ext. 438500

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Other Identifiers

V 07/06/2024

Identifier Type: -

Identifier Source: org_study_id