Clinical trial NCT06539923: Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes
Official title: Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes Applying to Tertiary Health Care Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Sarcopenia
Keywords: type 2 diabetes
sarcopenic index
Cystatin C
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 839
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were diagnosed with type 2 diabetes

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Age
timeFrame: baseline
measure: diabetes duration
timeFrame: baseline
measure: Glycemic control
timeFrame: baseline
measure: NT-proBNP
timeFrame: baseline
measure: FIB4 score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital
Study officials:
affiliation: Istanbul Medeniyet University
name: Ayse N Erbakan, MD
role: PRINCIPAL_INVESTIGATOR
References: