NCT07099937

Brief Summary

Evaluate the expression of glycemic parameters, lipid profile, and thyroid hormones in patients with type 2 diabetes mellitus in upper egypt.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Sep 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

July 18, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 18, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of thyroid dysfunction among type 2 diabetic patients

    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

    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

Interventions

This study does not involve any intervention. It is a cross-sectional observational study. The term "intervention" here refers to laboratory investigations and clinical assessments conducted as part of data collection only.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sakamoto M. Type 2 Diabetes and Glycemic Variability: Various Parameters in Clinical Practice. J Clin Med Res. 2018 Oct;10(10):737-742. doi: 10.14740/jocmr3556w. Epub 2018 Sep 10.

    PMID: 30214644BACKGROUND
  • Ford ES, Li C, Sattar N. Metabolic syndrome and incident diabetes: current state of the evidence. Diabetes Care. 2008 Sep;31(9):1898-904. doi: 10.2337/dc08-0423. Epub 2008 Jun 30.

    PMID: 18591398BACKGROUND
  • Hadgu R, Worede A, Ambachew S. Prevalence of thyroid dysfunction and associated factors among adult type 2 diabetes mellitus patients, 2000-2022: a systematic review and meta-analysis. Syst Rev. 2024 Apr 30;13(1):119. doi: 10.1186/s13643-024-02527-y.

    PMID: 38689302BACKGROUND
  • Chen H, Wu J, Lyu R. Expressions of glycemic parameters, lipid profile, and thyroid hormone in patients with type 2 diabetes mellitus and their correlation. Immun Inflamm Dis. 2024 Jul;12(7):e1282. doi: 10.1002/iid3.1282.

    PMID: 38967365BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Central Study Contacts

Ghada Ragab Hamed Abdelnasser, M.B.B.Ch

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 1, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07