NCT06829004

Brief Summary

Muscle mass is a critical indicator for malnutrition and sarcopenia assessment. Anthropometric measurements like calf circumference (CC) could be a simple and cost-effective alternative when gold standard methods are not available. However, CC is probably less accurate for estimating muscle mass in female patients and patients with obesity. This study investigates whether adjusting CC using mid-upper arm circumference (MUAC) improves muscle mass estimation in patients with obesity. If validated, this correction method would serve as a simple clinical tool for muscle mass assessment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Feb 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

February 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

February 4, 2025

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of corrected calf circumference in estimating muscle mass

    Accuracy of corrected calf circumference in estimating muscle mass in comparison to densitometry (DEXA) used as a gold standard

    15 months

Secondary Outcomes (4)

  • Comparison of accuracy of corrected calf measurement results in female patients

    15 months

  • Comparison of accuracy of corrected calf measurement results in obese patients

    15 months

  • Quality of life with and without corrected results of anthropometry

    15 months

  • Bone density estimated from corrected calf circumference

    15 months

Study Arms (1)

Patients undergoing bone density scanning at Tartu University Hospital

Patients undergoing bone density scanning at Tartu University Hospital selected from those attending the internal medicine clinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the internal medicine clinic for whom diagnostic bone density scanning (DEXA) has been requested by the physician normally responsible for the patient's care

You may qualify if:

  • Booked to undergo bone density scanning (DEXA) at Tartu University Hospital

You may not qualify if:

  • Isolation for infectious disease Pregnancy and lactation Unable to understand or follow study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Deutz NEP, Ashurst I, Ballesteros MD, Bear DE, Cruz-Jentoft AJ, Genton L, Landi F, Laviano A, Norman K, Prado CM. The Underappreciated Role of Low Muscle Mass in the Management of Malnutrition. J Am Med Dir Assoc. 2019 Jan;20(1):22-27. doi: 10.1016/j.jamda.2018.11.021.

    PMID: 30580819BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alastair Forbes, MD

    University of Tartu

    STUDY DIRECTOR

Central Study Contacts

Grete Kurik, MSc

CONTACT

Alastair Forbes, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Professor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 17, 2025

Study Start

February 15, 2025

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

February 17, 2025

Record last verified: 2025-02