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

NCT06913712 | Recruiting DMC

• 1 other identifier: V 07/06/2024
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments.
2. 2.To establish the BMI at which this disease occurs.
3. 3.To establish how much the BMI must be reduced to cure this disease.
4. 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

Conditions

Idiopathic Intracranial Hypertension (IIH)

Keywords

Idiopathic Intracranial Hypertension; Body Mass Index; Lumboperitoneal Shunt; Ventriculoperitoneal Shunt; Acetazolamide

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  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

Study Arms (1)

Patients with Idiopathic Intracranial Hypertension

Patients with Idiopathic Intracranial Hypertension

Other: Weight loss without pharmacotherapy

Interventions

Weight loss without pharmacotherapy 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.

Patients with Idiopathic Intracranial Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Vicente Vanaclocha, Professor

CONTACT

+ 34 963 13 18 00; vivava@uv.es

Teresa Moratal, Secretary

CONTACT

+ 34 963 13 18 00; moratal_ter@fihguv.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: April 6, 2025
• Study Start: June 27, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)