NCT06092307

Brief Summary

Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Evidence of the prevalence and incidence of sarcopenia in chronic pancreatitis is lacking, as well as studies which correlate sarcopenia to evolution of chronic pancreatitis.The main aim of this study is to evaluate whole body composition, sarcopenia, dynamic force tests, laboratory data at different stages of chronic pancreatitis. The accuracy of bioimpedance analysis and muscle ultrasound in the diagnosis of sarcopenia will also be assessed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 23, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 20, 2023

Last Update Submit

October 19, 2023

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (3)

  • sarcopenia prevalence in chronic pancreatitis

    skeletal muscle index (SMI) = skeletal muscle Area (SMA)/height

    three months

  • whole body composition in chronic pancreatitis

    measurement of skeletal muscle mass through bioelectrical impedance

    three months

  • dynamic muscle force

    Handgrip strength test using a hydraulic hand dynamometer

    three months

Study Arms (1)

Chronic pancreatitis

EXPERIMENTAL

adult patients aged 18-65 years with a diagnosis of chronic pancreatitis

Diagnostic Test: Bioelectrical impedanceDiagnostic Test: Handgrip strength testDiagnostic Test: muscle ultrasound.

Interventions

Bioelectrical impedanceDIAGNOSTIC_TEST

Resistance, reactance, phase angle,free-fat mass, body cell mass, body cell mass index and total body will be recorded

Chronic pancreatitis
Handgrip strength testDIAGNOSTIC_TEST

Handgrip strength test using a hydraulic hand dynamometer and sit-to-stand test will be performed.

Chronic pancreatitis
muscle ultrasound.DIAGNOSTIC_TEST

The following ultrasound parameters will be evaluated: radial, ulnar, rectus femoris, rectus abdominis and medial gastrocnemius muscle thickness and echo intensity with gray-scale-index; rectus femoris muscle cross sectional area; gastrocnemius muscle fiber length and pennation angle.

Chronic pancreatitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • diagnosis of chronic pancreatitis
  • age between 18 and 65 years,
  • abdominal CT or MRI into precedent maximum12 months.

You may not qualify if:

  • age less than 18 or older than 65 years
  • lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Electric Impedance

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Electric ConductivityElectricityElectromagnetic PhenomenaMagnetic PhenomenaPhysical Phenomena

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805mariaassunta.zocco@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 23, 2023

Study Start

April 18, 2023

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

October 23, 2023

Record last verified: 2023-09

Locations

IT(1)