NCT07244601

Brief Summary

  1. 1.Assess sarcopenia prevalence in elderly diabetic patients.
  2. 2.Evaluate impact of diabetes and its medications on muscle health.
  3. 3.detect effect of sacropenia on quality of life on elderly

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Dec 2025

Typical duration for all trials

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 Progress13%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2028

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

September 23, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of sarcopenia assessed by muscle ultrasound in elderly diabetic

    Sarcopenia will be evaluated using muscle ultrasound to measure muscle thickness and echo intensity of the quadriceps muscle. The results will be interpreted according to EWGSOP2 diagnostic criteria, which combine muscle mass and muscle strength parameters

    Within 6 months from the start of recruitment.

  • Assessment of muscle strength using handgrip dynamometry

    Handgrip strength will be measured using a handheld dynamometer, and the average of three attempts for the dominant hand will be recorded.

    Within 6 months

Secondary Outcomes (1)

  • Quality of life score using the SarQoL questionnaire.

    Within 6 months.

Study Arms (2)

Diabetic Group

Elderly patients with type 2 diabetes mellitus. Participants will be evaluated for the presence or absence of sarcopenia using muscle ultrasound and clinical criteria.

Diagnostic Test: muscle ultrasound

Non-Diabetic Group

Elderly patients without diabetes mellitus. Participants will also be assessed for sarcopenia using muscle ultrasound and standard diagnostic criteria.

Diagnostic Test: muscle ultrasound

Interventions

muscle ultrasoundDIAGNOSTIC_TEST

Bedside muscle ultrasound to measure muscle thickness, cross-sectional area and echogenicity

Diabetic GroupNon-Diabetic Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Inclusion criteria: The study will included all patient ,age ≥ 60 years,diagnosed with type 2 diabetes mellitus at least 5 years duraation according to ADA guideline referance(8) (diabetes can be made if a patient's A1C is 6.5% or higher, their FPG is 126 mg/dL or higher, or their 2-hour plasma glucose during an OGTT is 200 mg/dL or higher. A random plasma glucose of 200 mg/dL or higher, in conjunction with classic symptoms of hyperglycemia, also indicates diabetes) ●Able to give informed consent 2. Exclusion criteria: * chronic renal disease * chronic liver disese * Severe cognitive impairment * Known neuromuscular diseases affecting mobility * malignancy Data of the study will collected over one year duration from 1/2026 \_1/2027

You may qualify if:

  • The study will included all patient ,age ≥ 60 years,diagnosed with type 2 diabetes mellitus at least 5 years duraation according to ADA guideline referance(8) (diabetes can be made if a patient's A1C is 6.5% or higher, their FPG is 126 mg/dL or higher, or their 2-hour plasma glucose during an OGTT is 200 mg/dL or higher. A random plasma glucose of 200 mg/dL or higher, in conjunction with classic symptoms of hyperglycemia, also indicates diabetes)
  • ●Able to give informed consent

You may not qualify if:

  • chronic renal disease
  • chronic liver disese
  • Severe cognitive impairment
  • Known neuromuscular diseases affecting mobility
  • malignancy Data of the study will collected over one year duration from 1/2026 \_1/2027

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Feng L, Gao Q, Hu K, Wu M, Wang Z, Chen F, Mei F, Zhao L, Ma B. Prevalence and Risk Factors of Sarcopenia in Patients With Diabetes: A Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1470-1483. doi: 10.1210/clinem/dgab884.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

eman alaa eldean, master degree

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
house office of Internal Medicine, Assiut University

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 24, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

October 20, 2027

Study Completion (Estimated)

October 20, 2028

Last Updated

December 19, 2025

Record last verified: 2025-12