Observational cross-sectional study with no intervention. in Metabolic Syndrome and Type 2 Diabetes Mellitus (T2DM) and Thyroid Dysfunction - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Other: Observational cross-sectional study with no intervention.

Detailed Description

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion, resulting in persistent hyperglycemia. ( )..In T2DM, the response to insulin is diminished, and this is defined as insulin resistance. During this state, insulin is ineffective and is initially countered by an increase in insulin production to maintain glucose homeostasis, but over time, insulin production decreases, resulting in T2DM.( ).

Glycemic parameters are critical indicators for diagnosing and monitoring diabetes mellitus. The most commonly used measures include fasting blood glucose (FBG), postprandial blood glucose (PPBG), and glycated hemoglobin (HbA1c). Among them, HbA1c reflects the average blood glucose levels over the previous two to three months and is considered a reliable marker of chronic hyperglycemia.( ) Diabetic dyslipidemia constitutes a distinct cluster of plasma lipid and lipoprotein abnormalities that are metabolically interconnected in individuals with type 2 diabetes mellitus. This condition is predominantly characterized by elevated triglyceride (TG) concentrations, reduced levels of high-density lipoprotein cholesterol (HDL-C) ( ).

The underlying mechanism involves insulin resistance, which disrupts normal lipid metabolism by enhancing hepatic very low-density lipoprotein (VLDL) synthesis and impairing the clearance of triglyceride-rich lipoproteins. ( ) Prevalence of thyroid dysfunction is greater in diabetes patients compared to the general population.1-3 Prevalence of thyroid dysfunction in general population is around 6.6-13.4%, while in diabetes population around 10-24%.1 Studies found that subclinical hypothyroidism is the most common thyroid dysfunction in diabetic population ( ) Emerging evidence suggests a complex interplay between glycemic control, lipid metabolism, and thyroid function in patients with type 2 diabetes mellitus. Poor glycemic control has been associated with adverse lipid profiles and alterations in thyroid hormone levels, which may collectively contribute to the progression of diabetic complications. Thyroid hormones influence both glucose and lipid metabolism by regulating hepatic glucose production, lipolysis, and insulin sensitivity. ( ).

This study was conducted in Upper Egypt, a region characterized by distinct sociodemographic and health profiles compared to other parts of the country. Despite the growing burden of non-communicable diseases, including type 2 diabetes, there is a noticeable lack of regional epidemiological data addressing the coexistence of metabolic syndrome and thyroid dysfunction. Investigating this relationship in the Upper Egypt population may help fill existing knowledge gaps and support the development of more effective, geographically tailored healthcare strategies.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

Name: Ghada Ragab Hamed Abdelnasser, M.B.B.Ch
Phone Number: +20 1281862140
Email: Ghada.17289947@med.aun.edu.eg

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18 years and above diagnosed with type 2 diabetes mellitus attending the Diabetes and Endocrinology Outpatient Clinic at Assiut University Hospitals, Upper Egypt.

Description

Inclusion Criteria:

Patients diagnosed with type 2 diabetes mellitus in upper egypt.
Age above 18 years.
Patients who gave informed consent to participate.

Exclusion Criteria:

Patients with type 1 diabetes mellitus.
Age below 18 years.
Patients with known autoimmune thyroid diseases, pregnancy, or acute illness at the time of assessment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of thyroid dysfunction among type 2 diabetic patients Time Frame: Baseline	The outcome will measure the proportion (%) of type 2 diabetic patients diagnosed with thyroid dysfunction. This includes classification into hypothyroidism, hyperthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism based on standard laboratory cutoffs of TSH, free T3, and free T4.	Baseline
Association between thyroid dysfunction and metabolic syndrome in type 2 diabetic patients Time Frame: Baseline	The outcome will assess the statistical correlation (e.g., chi-square test or logistic regression) between the presence of thyroid dysfunction and the diagnosis of metabolic syndrome, according to IDF criteria. Results will be reported as odds ratios or p-values as appropriate.	Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 18, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Actual)