NCT06724068

Brief 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:

  • \[The difference of body composition between the individuals of insulin resistance and diabetes\]
  • \[The effect of diabetes on body composition\]

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 3, 2024

Last Update Submit

December 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Retrospective analysis of data collected between2019 and 2022

Study Arms (3)

Diabetes

Other: Diabetes,Insulin resistance,Control

Insulin resistance

Other: Diabetes,Insulin resistance,Control

Control

Other: Diabetes,Insulin resistance,Control

Interventions

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

ControlDiabetesInsulin resistance

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Song Xuan, Doctor

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

December 17, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations