Actively Recruiting

Age: 18Years +
All Genders
ID06913712

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

Led by University of Valencia · Updated on 2026-04-22

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the relationship between body mass index (BMI) changes and treatment response in people with Idiopathic Intracranial Hypertension (IIH). The study seeks to determine the BMI level at which IIH occurs, how much BMI needs to be lowered to resolve the condition, and how patients who do not lose weight or continue gaining weight respond to treatments such as Acetazolamide or cerebrospinal fluid (CSF) diversion procedures. It addresses the challenges patients face with weight loss and the complications linked to treatment failures and shunt system malfunctions. Participants will be observed without receiving medication to assist weight loss. Their weight will be recorded every three months and correlated with their response to treatments like weight loss alone, diuretic drugs (Acetazolamide), or surgical CSF diversion methods including lumboperitoneal or ventriculoperitoneal shunts. Bariatric surgery and endocrinology-recommended diets may be part of patient care, but weight loss medication is not used or approved in this study. During the study, participants will have their weight tracked regularly for about one year to assess how they respond to the various treatments. Researchers will measure treatment response over this period to understand the impact of BMI changes on IIH. The study does not provide treatments but observes existing approaches and their outcomes. The goal is to establish clearer BMI targets to help patients manage the disease effectively.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older at the time of enrollment
  • Confirmed diagnosis of Idiopathic Intracranial Hypertension based on Dandy criteria
  • Diagnostic process excludes other causes of increased intracranial pressure ensuring idiopathic cases
Not Eligible

You will not qualify if you...

  • Diagnosis of headache disorders other than Idiopathic Intracranial Hypertension such as tension-type headache or Chiari I malformation
  • Presence of secondary causes of increased intracranial pressure like structural brain abnormalities, venous sinus thrombosis, or medication-induced factors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Approximately 1 year

Participants with Idiopathic Intracranial Hypertension have their weight recorded every three months to assess response to different treatment modalities without additional medication for weight loss.

Quarterly visits every 3 months

Trial Site Locations

Total: 1 location

1

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, Spain, 46015

Actively Recruiting

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Research Team

V

Vicente Vanaclocha, Professor

T

Teresa Moratal, Secretary

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension.

Susan P Mollan, James L Mitchell, Andreas Yiangou...

https://pubmed.ncbi.nlm.nih.gov/35790425

The Health Economic Evaluation of Bariatric Surgery Versus a Community Weight Management Intervention Analysis from the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT).

Magda Aguiar, Emma Frew, Susan P Mollan...

https://pubmed.ncbi.nlm.nih.gov/33946177

Cost-effectiveness of bariatric surgery versus community weight management to treat obesity-related idiopathic intracranial hypertension: evidence from a single-payer healthcare system.

Laura Elliot, Emma Frew, Susan P Mollan...

https://pubmed.ncbi.nlm.nih.gov/33952427

Bariatric Surgery as a Viable Treatment for Idiopathic Intracranial Hypertension: a Case Series and Review of Literature.

Vimaladhithan Mahendran, Pol Ricart, Fridi Levine...

https://pubmed.ncbi.nlm.nih.gov/34322839

Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial.

Susan P Mollan, James L Mitchell, Ryan S Ottridge...

https://pubmed.ncbi.nlm.nih.gov/33900360

Midterm benefits of metabolic surgery on symptom remission and medication use in patients with pseudotumor cerebri.

Luis Felipe Okida, Tara Salimi, Rene Aleman...

https://pubmed.ncbi.nlm.nih.gov/36549974