Type 2 DiabetesNCT06539923
Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes and Sarcopenia, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Sarcopenia
- What is being tested?
- retrieving data
- How many people
- 839 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were diagnosed with type 2 diabetes
Who may be able to join
- type 2 diabetes diagnosis
- with complete biochemical data on record
Who cannot join
- acute infection,
- steroid use,
- acute changes in creatinine or cystatin C levels,
- recent surgery,
- limb loss.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes Applying to Tertiary Health Care Services
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Sarcopenia
- Being tested
- retrieving data
- Keywords
- type 2 diabetes, sarcopenic index, Cystatin C
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrieving dataOther
Data will be retrieved retrospectively
| Study group | Role | What they receive |
|---|---|---|
| T2DM patients | patients with definite type 2 diabetes diagnosis Receives: Other: retrieving data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
relationship between sarcopenic index and age
Measured: baseline
diabetes duration
relationship between sarcopenic index and diabetes duration
Measured: baseline
Glycemic control
relationship between sarcopenic index and glycemic control using HbA1c levels
Measured: baseline
NT-proBNP
relationship between sarcopenic index and NT-proBNP (NT terminal pro-brain natriuretic peptide-use for assessing heart failure) levels
Measured: baseline
FIB4 score
relationship between sarcopenic index and Fib4 score ( reflecting hepatic fibrosis risk)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Ayse N Erbakan, MD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539923
- Sponsor's protocol ID
- SI in T2DM
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes Applying to Tertiary Health Care Services
- ClinicalTrials.gov ID
- NCT06539923
- Acronym / sponsor ID
- SI in T2DM
- Conditions
- Type 2 Diabetes, Sarcopenia
- Keywords
- type 2 diabetes, sarcopenic index, Cystatin C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM patients | – | Other: retrieving datapatients with definite type 2 diabetes diagnosis |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were diagnosed with type 2 diabetes
Key inclusion criteria (2 listed)
- type 2 diabetes diagnosis
- with complete biochemical data on record
Key exclusion criteria (5 listed)
- acute infection,
- steroid use,
- acute changes in creatinine or cystatin C levels,
- recent surgery,
- limb loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrieving dataData will be retrieved retrospectively | Other | T2DM patients |
Primary outcome
Age
Time frame: baseline
relationship between sarcopenic index and age
diabetes duration
Time frame: baseline
relationship between sarcopenic index and diabetes duration
Glycemic control
Time frame: baseline
relationship between sarcopenic index and glycemic control using HbA1c levels
NT-proBNP
Time frame: baseline
relationship between sarcopenic index and NT-proBNP (NT terminal pro-brain natriuretic peptide-use for assessing heart failure) levels
FIB4 score
Time frame: baseline
relationship between sarcopenic index and Fib4 score ( reflecting hepatic fibrosis risk)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse N Erbakan, MD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Sarcopenia, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.