Diabetes, Insulin Resistance and Body Composition

December 7, 2024 updated by: Xuan Song

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]

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Adults aged 18 years and older.
  2. Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.
  3. Availability of complete body composition data (e.g., DXA measurements).
  4. Documented HbA1c levels and other glycemic control data.
  5. Continuous medical records available during the study period

Exclusion Criteria:

  1. Presence of other severe metabolic diseases, such as liver failure or kidney failure.
  2. Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.
  3. History of malignancy or ongoing treatment for cancer.
  4. Missing critical research data (e.g., diabetes duration or HbA1c levels).
  5. History of surgeries causing significant body composition changes (e.g., bariatric surgery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Other: Diabetes，Insulin resistance，Control
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
Diabetes
Other: Diabetes，Insulin resistance，Control
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
Insulin resistance
Other: Diabetes，Insulin resistance，Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Retrospective analysis of data collected between2019 and 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuan Song

Investigators

  • Principal Investigator: Song Xuan, Doctor, The First Affiliated Hospital of Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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