Diagnostic Performance of Controlling Nutritional Status... | NCT06648551

Studies
Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease

NCT06648551

Sponsor

Hospital General de Mexico

Status

Recruiting

Last Update Posted

Oct 18, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Disease 5

Interventions

CONUT

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2023Actual

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Oct 28, 2027Estimated

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Oct 16, 2024

First Posted Date

Oct 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2024

Last Update Posted Date

Oct 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nallely Bueno Hernández, Medical Sciences Researcher C, Hospital General de MexicoPrincipal Investigator

Lead Sponsor

Hospital General de MexicoOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are:

What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease?

The participants will:

Undergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CONUT	Diagnostic Test	It is a scale that uses albumin, lymphocytes, and cholesterol for the diagnosis of malnutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic test	sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years and older
Gender unspecified
Histologically confirmed Ulcerative Colitis
Diagnosis confirmed by a specialist physician

Exclusion Criteria:

Patients with any amputation or prosthesis
Patients with a pacemaker
Patients with any neoplasm
Pregnancy or lactation
With comorbidities such as diabetes, hypertension, heart failure, thyroid problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Ulcerative Colitis patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nallely Hernandez Bueno	Recruiting	Mexico City	Cuauhtemoc	06720	Mexico

Condition Browse Module

MeSH Terms

ID	Term
C565234	Inflammatory Bowel Disease 5

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided