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

April 18, 2026 updated by: Vicente Vanaclocha, University of Valencia

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

  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vicente Vanaclocha, Professor
  • Phone Number: 438500 + 34 963 13 18 00
  • Email: vivava@uv.es

Study Contact Backup

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46015
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
        • Contact:
          • Vicente Vanaclocha, Professor
          • Phone Number: 438500 +34 963 13 18 00
          • Email: vivava@uv.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is designed to be a retrospective-prospective cohort study. Data was collected from all retrospective patients attended in the last 10 years by the Neurosurgery department at Hospital General Universitario de Valencia who presented idiopathic intracranial hypertension (IIH) and were accepted to participate. Data were extracted and reviewed from the patient's medical records.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Idiopathic Intracranial Hypertension
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment
Time Frame: Through study completion, an average of 1 year
BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V 07/06/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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