Sex-specific Differences in the Association Between Leg Fat and Diabetes Risk

NCT07261800 | Completed

• 1 other identifier: S877
• Study Type: observational
• Target: 542
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the association between LFP, VAT and T2DM using DXA in 542 adults. We apply penalized regression, generalized additive models (GAM), and causal mediation analysis to explore whether higher LFP reduces diabetes risk and whether this effect is mediated by VAT. Sex-specific analyses further clarify the biological differences in adipose distribution. The findings aim to improve understanding of fat distribution and metabolic health.

Conditions

Diabetes Mellitus; Visceral Adipose Tissue; Body Fat Distribution

Outcome Measures

Primary Outcomes (1)

• Prevalence of diabetes in relation to lower extremity fat

  T2DM will be defined according to standard diagnostic criteria (fasting plasma glucose ≥ 7.0 mmol/L and/or HbA1c ≥ 6.5%, or a physician diagnosis). The primary outcome is the association between LFP and diabetes status, estimated using multivariable logistic regression and causal mediation analysis.

  Baseline

Secondary Outcomes (2)

• Mediating Effect of VAT

  baseline

• Sex-specific Differences in the LFP-T2D Association

  Baseline

Other Outcomes (2)

• Nonlinear Relationship Between LFP/VAT and T2D Risk (GAM Analysis)

  baseline

• Causal Association Between Genetically Predicted LFP and T2D (Mendelian Randomization)

  baseline

Study Arms (2)

diabetes group

Participants diagnosed with type 2 diabetes based on clinical guidelines, including elevated fasting plasma glucose (FPG) and/or HbA1c levels. This group will help assess how regional fat distribution (particularly leg-fat percentage) correlates with T2D risk.

Other: Not Applicable - Retrospective study

non-diabetes group

Participants without T2DM, with normal glucose metabolism and no history of insulin resistance. This group is used as a reference for comparing the metabolic effects of adipose distribution with the T2DM group.

Other: Not Applicable - Retrospective study

Interventions

Not Applicable - Retrospective study OTHER

Not Applicable - Retrospective study

diabetes group; non-diabetes group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who underwent DXA examination and had complete clinical and biochemical data.

You may qualify if:

• Adults (≥18 years old)
• Available DXA measurement of fat distribution
• Complete fasting glucose or diabetes diagnosis record

You may not qualify if:

• Missing key variables (fat distribution, diabetes status)
• Severe systemic disease interfering with data integrity
• Implausible or inconsistent records

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xuan Song

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated physician

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: December 3, 2025
• Study Start: December 31, 2024
• Primary Completion: February 12, 2025
• Study Completion: August 10, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)