NCT03214068

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

July 6, 2017

Last Update Submit

May 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thyroid stimulating hormone

    Evaluation of thyroid dysfunctions in patients with metabolic syndrome

    2 years.

Secondary Outcomes (1)

  • Lipid profile

    2 years

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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 .

You may qualify if:

  • 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.
  • knownly diagnosed diabetes mellitus .
  • hypertension diagnosed patients .
  • obese patients.

You may not qualify if:

  • \. Patients with liver disorders, renal disorders, congestive cardiac failure, pregnant women.
  • \. Patients with history of respiratory disease, malignancy, Smokers, alcoholics, 4. patients receiving medication that may alter thyroid functions or lipid levels,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Asyut, Egypt

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor of internal medicine

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 11, 2017

Study Start

July 5, 2018

Primary Completion

September 5, 2018

Study Completion

December 5, 2018

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access

Locations