NCT06539923

Brief Summary

Sarcopenia, characterized by a progressive loss of skeletal muscle mass and function, is particularly common in individuals with T2DM and is often associated with insulin resistance, chronic inflammation and oxidative stress. The Sarcopenia Index (SI), calculated as serum creatinine divided by serum cystatin C, is a practical tool for assessing sarcopenia and is used in many clinical settings. In this study, we aimed to investigate the relationship between sarcopenic index and variables such as age, diabetes duration, diabetes control and complication-related parameters such as NT-proBNP and Fib4 score in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
839

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 1, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

type 2 diabetessarcopenic indexCystatin C

Outcome Measures

Primary Outcomes (5)

  • Age

    relationship between sarcopenic index and age

    baseline

  • diabetes duration

    relationship between sarcopenic index and diabetes duration

    baseline

  • Glycemic control

    relationship between sarcopenic index and glycemic control using HbA1c levels

    baseline

  • NT-proBNP

    relationship between sarcopenic index and NT-proBNP (NT terminal pro-brain natriuretic peptide-use for assessing heart failure) levels

    baseline

  • FIB4 score

    relationship between sarcopenic index and Fib4 score ( reflecting hepatic fibrosis risk)

    baseline

Study Arms (1)

T2DM patients

patients with definite type 2 diabetes diagnosis

Other: retrieving data

Interventions

Data will be retrieved retrospectively

T2DM patients

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who were diagnosed with type 2 diabetes

You may qualify if:

  • type 2 diabetes diagnosis
  • with complete biochemical data on record

You may not qualify if:

  • acute infection,
  • steroid use,
  • acute changes in creatinine or cystatin C levels,
  • recent surgery,
  • limb loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sarcopenia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Ayse N Erbakan, MD

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 6, 2024

Study Start

July 1, 2024

Primary Completion

July 31, 2024

Study Completion

August 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations