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NCT Number: NCT06539923

Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Atrophy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

About this study

This study was planned retrospectively. Between September 01, 2023 and March 31, 2024, the records of patients who presented to the Diabetes Outpatient Clinic of Goztepe Prof. Dr. Suleyman Yalcin City Hospital for Internal Medicine and whose routine biochemical tests (including NT-proBNP and cystatin C) were found in the system will be retrospectively reviewed. Both male and female patients with a definite diagnosis of type 2 diabetes were included in the study. Inclusion criteria included: age 40 years or older, age 85 years or younger, no acute infection, no steroid use, no acute changes in creatinine or cystatin C levels, no recent surgery, no limb loss. Demographic data included age, gender, duration of diabetes, medications and concomitant diseases. The Fib 4 score was calculated using the patients' routine biochemical and hematologic results. The sarcopenia index was calculated from the serum creatinine/cystatin C values. A cut-off value of 0.90 is normally used for the diagnosis of sarcopenia in people without diabetes, but there is no cut-off value for patients with diabetes. Therefore, in addition to the correlation, the SI value was divided into 3 groups and the patients in the lowest and highest groups were compared with each other.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

retrieving data

Other

Data will be retrieved retrospectively

Primary outcomes

  1. Age

    Time frame: baseline

    relationship between sarcopenic index and age

  2. diabetes duration

    Time frame: baseline

    relationship between sarcopenic index and diabetes duration

  3. Glycemic control

    Time frame: baseline

    relationship between sarcopenic index and glycemic control using HbA1c levels

  4. NT-proBNP

    Time frame: baseline

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

  5. FIB4 score

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Other

Registry information

Official study title

Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes Applying to Tertiary Health Care Services

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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