Type 2 Diabetes Mellitus (T2DM)NCT07099937
Relationship Between Thyroid Dysfunction and Diabetes
An observational study of Type 2 Diabetes Mellitus (T2DM) and Thyroid Dysfunction, run by Assiut University.
Trial summary
Evaluate the expression of glycemic parameters, lipid profile, and thyroid hormones in patients with type 2 diabetes mellitus in upper egypt. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Thyroid Dysfunction, Metabolic Syndrome
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with type 2 diabetes mellitus in upper egypt.
- Age above 18 years.
- Patients who gave informed consent to participate.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Metabolic Syndrome and Thyroid Dysfunction in Type 2 Diabetes In Upper Egypt
Evaluate the expression of glycemic parameters, lipid profile, and thyroid hormones in patients with type 2 diabetes mellitus in upper egypt.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Thyroid Dysfunction, Metabolic Syndrome, Upper Egypt Patients
- Being tested
- Observational cross-sectional study with no intervention.
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cross-sectional study with no intervention.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ragab Hamed Abdelnasser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099937
- Sponsor's protocol ID
- thyroid and diabetes mellitus
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30214644Ford 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.
PubMed 18591398Hadgu 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.
PubMed 38689302Chen 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.
PubMed 38967365
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Thyroid Dysfunction in Type 2 Diabetes In Upper Egypt
- ClinicalTrials.gov ID
- NCT07099937
- Acronym / sponsor ID
- thyroid and diabetes mellitus
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Thyroid Dysfunction, Metabolic Syndrome, Upper Egypt Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the expression of glycemic parameters, lipid profile, and thyroid hormones in patients with type 2 diabetes mellitus in upper egypt.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients diagnosed with type 2 diabetes mellitus in upper egypt.
- Age above 18 years.
- Patients who gave informed consent to participate.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational cross-sectional study with no intervention.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. | Other | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 30214644Sakamoto 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.
- Background: PubMed 18591398Ford 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.
- Background: PubMed 38689302Hadgu 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.
- Background: PubMed 38967365Chen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Recruiting
Achieving Routine Intervention and Screening for Emotional Health
Type 2 Diabetes Mellitus (T2DM), Diabetes Distress
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
RecruitingPhase 2
A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Thyroid Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada Ragab Hamed Abdelnasser, M.B.B.Ch (+20 1281862140, Ghada.17289947@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of thyroid dysfunction among type 2 diabetic patients (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07099937, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.