Insulin Resistance, DiabetesNCT06724068
Diabetes, Insulin Resistance and Body Composition
An observational study of Insulin Resistance, Diabetes, run by Xuan Song at 1 site in China.
Trial summary
The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions. The main question[s] it aims to answer are: [The difference of body composition between the individuals of insulin resistance and diabetes] [The effect of diabetes on body composition] Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Diabetes
- How many people
- 515 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2021to 31 Aug 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes adult patients aged 18 years and older who were diagnosed with type 2 diabetes mellitus. The population consists of individuals with documented medical records, including diabetes duration, glycemic control data (HbA1c levels), and body composition measurements such as muscle mass assessments. The study also includes a control group of non-diabetic individuals matched by age and sex to enable comparative analysis.
Who may be able to join
- Adults aged 18 years and older.
- Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.
- Availability of complete body composition data (e.g., DXA measurements).
- Documented HbA1c levels and other glycemic control data.
- Continuous medical records available during the study period
Who cannot join
- Presence of other severe metabolic diseases, such as liver failure or kidney failure.
- Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.
- History of malignancy or ongoing treatment for cancer.
- Missing critical research data (e.g., diabetes duration or HbA1c levels).
- History of surgeries causing significant body composition changes (e.g., bariatric surgery).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: The Correlation Between Diabetes, Insulin Resistance and Body Composition
The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions.
The main question[s] it aims to answer are:
- [The difference of body composition between the individuals of insulin resistance and diabetes]
- [The effect of diabetes on body composition]
- Conditions
- Insulin Resistance, Diabetes
- Being tested
- Diabetes，Insulin resistance，Control
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes，Insulin resistance，ControlOther
This retrospective study uses medical records and diagnostic data from patients with type 2 diabetes and healthy controls obtained from Qianfoshan Hospital from2019 to 2022
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Not described Receives: Other: Diabetes，Insulin resistance，Control | |
| Insulin resistance | Not described Receives: Other: Diabetes，Insulin resistance，Control | |
| Control | Not described Receives: Other: Diabetes，Insulin resistance，Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sarcopenia in Diabetic Patients
The proportion of diabetic patients diagnosed with sarcopenia, assessed based on measurements of muscle mass, muscle strength, and physical performance. Sarcopenia will be defined according to AWGS 2019 and EWGSOP2
Measured: Retrospective analysis of data collected between2019 and 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start17 Dec 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistance, 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
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuan Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuan Song, Qianfoshan Hospital
- Investigators
- Song Xuan, Doctor, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724068
- Sponsor's protocol ID
- S1181
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Diabetes, Insulin Resistance and Body Composition
- ClinicalTrials.gov ID
- NCT06724068
- Acronym / sponsor ID
- S1181
- Conditions
- Insulin Resistance, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Xuan SongUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Dec 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.
The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions.
The main question[s] it aims to answer are:
- [The difference of body composition between the individuals of insulin resistance and diabetes]
- [The effect of diabetes on body composition]
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Other: Diabetes，Insulin resistance，Control |
| Insulin resistance | – | Other: Diabetes，Insulin resistance，Control |
| Control | – | Other: Diabetes，Insulin resistance，Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients aged 18 years and older who were diagnosed with type 2 diabetes mellitus. The population consists of individuals with documented medical records, including diabetes duration, glycemic control data (HbA1c levels), and body composition measurements such as muscle mass assessments. The study also includes a control group of non-diabetic individuals matched by age and sex to enable comparative analysis.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older.
- Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.
- Availability of complete body composition data (e.g., DXA measurements).
- Documented HbA1c levels and other glycemic control data.
- Continuous medical records available during the study period
Key exclusion criteria (5 listed)
- Presence of other severe metabolic diseases, such as liver failure or kidney failure.
- Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.
- History of malignancy or ongoing treatment for cancer.
- Missing critical research data (e.g., diabetes duration or HbA1c levels).
- History of surgeries causing significant body composition changes (e.g., bariatric surgery).
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 |
|---|---|---|
| Diabetes，Insulin resistance，ControlThis retrospective study uses medical records and diagnostic data from patients with type 2 diabetes and healthy controls obtained from Qianfoshan Hospital from2019 to 2022 | Other | Control, Diabetes, Insulin resistance |
Primary outcome
Prevalence of Sarcopenia in Diabetic Patients
Time frame: Retrospective analysis of data collected between2019 and 2022
The proportion of diabetic patients diagnosed with sarcopenia, assessed based on measurements of muscle mass, muscle strength, and physical performance. Sarcopenia will be defined according to AWGS 2019 and EWGSOP2
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 12 Dec 2024.
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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.
Song Xuan, Doctor principal investigator
Shandong First Medical 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 Insulin Resistance, Diabetes, run by Xuan Song at 1 site in China.
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 5 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 12 Dec 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 China. 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?
Prevalence of Sarcopenia in Diabetic Patients (time frame: Retrospective analysis of data collected between2019 and 2022). 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 12 Dec 2024.