Association of Inflammatory Factors With Complications in the Diabetic Population: a Cross-sectional Study

This study is a cross-sectional study of patients with diabetes. The main purpose of this study is to explore the relationship between inflammatory indicators, but not limited to inflammatory indicators, and diabetes complications, in order to find early predictors and screen out high-risk groups.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus

Detailed Description

Diabetes is one of the most important public health challenges of the 21st century, placing a heavy burden on societies and economies. The World Health Organization estimates that more than 10% of the world's population has diabetes or is at high risk of developing it. With the change of lifestyle, the number of people with diabetes is increasing, the types of complications are more and more complicated, and the time of complications is more and more earlier. Studies have found that the mechanism of diabetes has far exceeded the traditional mechanisms such as insulin resistance and glucose intolerance in the past, and the role of chronic low-grade inflammation in the whole course of diabetes should not be underestimated. At present, more and more researchers have explored the relationship between inflammation and certain clinical outcomes, such as diabetes, diabetes-related complications, hyperlipidemia, myocardial infarction, stroke, aneurysm, bladder cancer, etc.

The study found that people with diabetes had higher levels of inflammation than those without diabetes, with a statistically significant difference, and among people with diabetes, those with severe complications had higher levels of diabetes than those without complications, with a statistically significant difference. Jiachen Luo's study also confirmed that higher SII was associated with a poorer prognosis in patients with diabetes complicated by an acute myocardial infarction event. Nayili Mahemuti et al. 's analysis of NHANES found a positive association between SII and the risk of hyperlipidemia. Paul M Ridker also analyzed the participants in the PROMINENT, REDUCEIT and STRENGTH trials, which included participants who were taking statins and diagnosed with coronary atherosclerosis. CRP was found to be significantly associated with the occurrence of several adverse cardiovascular events (highest high-sensitive CRP quartile vs lowest high-sensitive CRP quartile, adjusted HR 1.31, 95% CI 1.20-1.43; P < 0.0001). The body is a complex and complex system, with glucose metabolism, lipid metabolism, inflammatory metabolism and other systems closely related. The physiological and pathological changes of diabetes stimulate the activation of chronic, low-grade and non-infectious inflammation in the body, while long-term inflammatory factors act on various tissues, organs and systems of the body, which in turn aggravate the occurrence and development of diabetes, making diabetes and inflammation cause and effect each other. On the basis of traditional inflammatory indicators, many new inflammatory indicators have been derived, and the relationship between these indicators and clinical outcomes has not been fully explored. It is of great significance to investigate the relationship between inflammation and diabetic complications.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Mengchen Zou Zou, Professor; Phone Number: +86 18688423756; Email: zoumc163@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
      • Contact: Mengchen Zou Professor; Phone Number: 18688423756; Email: zoumc163@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Diabetic patients with or without complications

Description

Inclusion Criteria:

• Patients with a normative diagnosis of type 2 diabetes
• Age ≥20 years old, regardless of gender
• From January 2018 to August 2023, he was treated in Nanfang Hospital

Exclusion Criteria:

• In the acute infection phase
• The researchers judged that it was not suitable to participate in this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1.with complications 2.without complications; non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	Data on inflammatory markers measured during hospitalization were collected in international units. C-reactive protein was measured and reported by the clinical laboratory of Nanfang Hospital under the condition of fasting.	In November-december 2024

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: NFEC-2024-468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No