Metabolic SyndromeNCT03214068
Evaluation of the Pattern of Thyroid Dysfunctions in Patients With Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
The study on evaluation the pattern of TD in MetS population may help us to know the magnitude of overlap of these two disease entities and may highlight the importance of thyroid function tests in patients with MetS. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2018to 5 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include 100 patients with metabolic syndrome (MetS) who fulfilled criteria according to the 2005 Revised National Cholesterol Education Program/ATP III. Age and sex matched100 healthy persons who have no features of metabolic syndrome will be included in the study as a control group .
Who may be able to join
- Patients satisfying the 2005 Revised National Cholesterol Education Program/AdenosineTri Phosphate III which have three out of five of the following criteria:
- Central obesity - defined as waist circumference ≥102 cm for Men and ≥88cm for women.
- Raised triglycerides: ≥ 150 mg/dL, or specific treatment for this lipid abnormality.
- Reduced HDL cholesterol: < 40 mg/dL in males,< 50 mg/dL in females, or specific treatment for this lipid abnormality
- Raised blood pressure: systolic BP ≥130 or diastolic BP ≥85 mm Hg, or treatment of previously diagnosed hypertension.
- Raised fasting plasma glucose :( FPG) ≥100 mg /dL, or previously diagnosed type 2 diabetes.
Show all 13Show fewer
- knownly diagnosed diabetes mellitus .
- hypertension diagnosed patients .
- obese patients.
- Exclusion Criteria: 1. Known hypothyroid or sub-clinical hypothyroid or hyperthyroid patients or on treatment.
- 2. Patients with liver disorders, renal disorders, congestive cardiac failure, pregnant women.
- 3. Patients with history of respiratory disease, malignancy, Smokers, alcoholics, 4. patients receiving medication that may alter thyroid functions or lipid levels,
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The study on evaluation the pattern of TD in MetS population may help us to know the magnitude of overlap of these two disease entities and may highlight the importance of thyroid function tests in patients with MetS. This can lead to proper planning and adequate management strategies, resulting in significant reduction in cardiovascular morbidity and mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in patients with MetS and to explore the relationship between TD and components of the MetS.
Read the detailed description
The metabolic syndrome (MetS) is a clustering of multiple risk factors for atherosclerotic cardiovascular disease such as central obesity, impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM), elevated triglyceride (TG), reduced high density lipoprotein cholesterol (HDL-C) and hypertension (HTN).This cluster of metabolic abnormalities is associated with increased risk for atherosclerotic cardiovascular disease and type 2 diabetes mellitus Despite of the controversy on its definition, it is estimated that one out of four people around the world suffers from MetS. The prevalence of MetS is increasing all over the world.
Thyroid hormones play an important role in regulating energy homeostasis, carbohydrate, lipids and protein metabolism. These hormones accelerate metabolic processes and may be associated with metabolic syndrome. Hyperthyroidism is usually associated with low cholesterol and glucose intolerance; whereas hypothyroidism is associated with high cholesterol tendency, and patients are prone to weight gain and cardiac signs like bradycardia. Thyroid functions affect the components of MetS including HDLcholesterol (HDL-C), triglycerides (TG), blood pressure and plasma glucose.
Thyroid dysfunction (TD) is defined as the altered serum thyroid stimulating hormone (TSH) level with normal or altered thyroid hormones (free triiodothyronine and free thyroxine.TD is risk factors for CardioVascular Disease mediated by the effects of thyroid hormones on lipid and glucose metabolism and blood pressure, hence on components of MetS.MetS and TD are both characterized by a cluster of common abnormalities such as abdominal obesity, hyperglycemia, HTN, reduced HDL-C, and elevated TG and recognized independent risk factors of ASCVD ..Thyroid dysfunction, prominently subclinical hypothyroidism has been observed more frequently in metabolic syndrome patients than general population .
The study on evaluation the pattern of TD in MetS population may help us to know the magnitude of overlap of these two disease entities and may highlight the importance of thyroid function tests in patients with MetS. This can lead to proper planning and adequate management strategies, resulting in significant reduction in cardiovascular morbidity and mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in patients with MetS and to explore the relationship between TD and components of the MetS.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid stimulating hormone
Evaluation of thyroid dysfunctions in patients with metabolic syndrome
Measured: 2 years.
Secondary outcomes (1)
Lipid profile
To evaluate the associations between thyroid hormones levels and components of metabolic syndrome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start5 Jul 2018
- Primary completion5 Sep 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAAbdelhay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214068
- Sponsor's protocol ID
- 17100051
- Status last verified
- May 2020
- First submitted
- 6 Jul 2017
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Udenze I, Nnaji I, Oshodi T. Thyroid function in adult Nigerians with metabolic syndrome. Pan Afr Med J. 2014 Aug 29;18:352. doi: 10.11604/pamj.2014.18.352.4551. eCollection 2014.
PubMed 25574328
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pattern of Thyroid Dysfunctions in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03214068
- Acronym / sponsor ID
- 17100051
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 11 Jul 2017 (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.
The study on evaluation the pattern of TD in MetS population may help us to know the magnitude of overlap of these two disease entities and may highlight the importance of thyroid function tests in patients with MetS. This can lead to proper planning and adequate management strategies, resulting in significant reduction in cardiovascular morbidity and mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in patients with MetS and to explore the relationship between TD and components of the MetS.
Detailed description
The metabolic syndrome (MetS) is a clustering of multiple risk factors for atherosclerotic cardiovascular disease such as central obesity, impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM), elevated triglyceride (TG), reduced high density lipoprotein cholesterol (HDL-C) and hypertension (HTN).This cluster of metabolic abnormalities is associated with increased risk for atherosclerotic cardiovascular disease and type 2 diabetes mellitus Despite of the controversy on its definition, it is estimated that one out of four people around the world suffers from MetS. The prevalence of MetS is increasing all over the world.
Thyroid hormones play an important role in regulating energy homeostasis, carbohydrate, lipids and protein metabolism. These hormones accelerate metabolic processes and may be associated with metabolic syndrome. Hyperthyroidism is usually associated with low cholesterol and glucose intolerance; whereas hypothyroidism is associated with high cholesterol tendency, and patients are prone to weight gain and cardiac signs like bradycardia. Thyroid functions affect the components of MetS including HDLcholesterol (HDL-C), triglycerides (TG), blood pressure and plasma glucose.
Thyroid dysfunction (TD) is defined as the altered serum thyroid stimulating hormone (TSH) level with normal or altered thyroid hormones (free triiodothyronine and free thyroxine.TD is risk factors for CardioVascular Disease mediated by the effects of thyroid hormones on lipid and glucose metabolism and blood pressure, hence on components of MetS.MetS and TD are both characterized by a cluster of common abnormalities such as abdominal obesity, hyperglycemia, HTN, reduced HDL-C, and elevated TG and recognized independent risk factors of ASCVD ..Thyroid dysfunction, prominently subclinical hypothyroidism has been observed more frequently in metabolic syndrome patients than general population .
The study on evaluation the pattern of TD in MetS population may help us to know the magnitude of overlap of these two disease entities and may highlight the importance of thyroid function tests in patients with MetS. This can lead to proper planning and adequate management strategies, resulting in significant reduction in cardiovascular morbidity and mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in patients with MetS and to explore the relationship between TD and components of the MetS.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 100 patients with metabolic syndrome (MetS) who fulfilled criteria according to the 2005 Revised National Cholesterol Education Program/ATP III. Age and sex matched100 healthy persons who have no features of metabolic syndrome will be included in the study as a control group .
Key inclusion criteria (13 listed)
- Patients satisfying the 2005 Revised National Cholesterol Education Program/AdenosineTri Phosphate III which have three out of five of the following criteria:
- Exclusion Criteria: 1. Known hypothyroid or sub-clinical hypothyroid or hyperthyroid patients or on treatment.
- 2. Patients with liver disorders, renal disorders, congestive cardiac failure, pregnant women.
- 3. Patients with history of respiratory disease, malignancy, Smokers, alcoholics, 4. patients receiving medication that may alter thyroid functions or lipid levels,
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thyroid stimulating hormone
Time frame: 2 years.
Evaluation of thyroid dysfunctions in patients with metabolic syndrome
1 secondary outcome
Lipid profile
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Results publication: PubMed 25574328Udenze I, Nnaji I, Oshodi T. Thyroid function in adult Nigerians with metabolic syndrome. Pan Afr Med J. 2014 Aug 29;18:352. doi: 10.11604/pamj.2014.18.352.4551. eCollection 2014.
- Thyroid function in adult Nigerians with metabolic syndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Assiut University at 1 site in Egypt.
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 13 inclusion and 0 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: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid stimulating hormone (time frame: 2 years.). 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 NCT03214068, which also lists 1 linked publication.
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 5 May 2020.