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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06092021
Other study ID # Cardiovascular obesity
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source Assiut University
Contact Asmaa Sayed
Phone 0101 289 2990
Email Asmaakhaled992@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine the association between obesity phenotypes with cardiovascular diseases. - Primary Outcomes: 1- To examine the association between different obesity phenotypes and cardiovascular diseases.by using echocardiography, lipid profile - Secondary Outcomes: 1. frequency of obesity phenotypes on our locality 2. Correlation between each type of obesity phenotypes and other metabolic disturbances (e.g. DM, dyslipidemia, NASH) 3. Correlation between epcardial fat, carotid intimal thickness and different obesity phenotypes.


Description:

Obesity is a condition caused by increasing the fat components of body resulting in body weight increase. Obesity leads to several complications like type 2 diabetes, hypertension and cardiovascular events, sleep apnea. But obesity can no longer be evaluated solely by the body mass index (expressed in kg/m2) because it represents a heterogeneous entity (1). As there are several cardio-metabolic imaging studies have shown that some individuals who have a normal weight or who are overweight are at high risk if they have an excess of visceral adipose tissue-a condition often accompanied by accumulation of fat in normally lean tissues (ectopic fat deposition in liver, heart, skeletal muscle, etc.) (2) On the other hand, individuals who are overweight or obese can nevertheless be at much lower risk than expected when faced with excess energy intake if they have the ability to expand their subcutaneous adipose tissue mass, particularly in the gluteal-femoral area, as preferential fat storage in the lower body depot may act as a metabolic buffer and protect other tissues from lipotoxicity caused by lipid overflow and ectopic fat (3). Hence, excessive amounts of visceral adipose tissue and of ectopic fat largely define the cardiovascular disease risk of overweight and moderate obesity (4). Epicardial fat is considered as indicator of cardiovascular risk. Several studies have tested the association between epicardial fat thickness (EFT) and coronary artery disease many studies stated that epicardial fat is independently and linearly associated with CAD and its severity .In this study we aim to monitor the extent of obesity phenotypes association to cardiovascular diseases in patients attending to Obesity Clinic in Assuit Hospital University.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Adult patient of 18 years old and above Exclusion Criteria: - 1- Patients below 18 years old age (pediatrics and Child). 2- Pregnant females. 3- Patients with congenital heart diseases. 4- Patients with previous bariatric surgery. 5-Patients with type 1 DM. 6-Patients with hereditary hyperlipidemia .Secondary causes of obesity include these:Endocrine DisordersCushing SyndromeHypothyroidismPseudohypoparathyroidismType 2 diabetes Genetic SyndromesPrader-Willi syndromeBardet-Biedel syndromeCohen syndromeCentral Nervous System DisordersHypothalamic TumorTrauma to or inflammation of the hypothalamic regionOtherDrug induced - atypical anti-psychotics, tricyclic antidepressantsBinge eating disorderBulimia nervosa

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Asmaa khaled sayed Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Piche ME, Tchernof A, Despres JP. Obesity Phenotypes, Diabetes, and Cardiovascular Diseases. Circ Res. 2020 May 22;126(11):1477-1500. doi: 10.1161/CIRCRESAHA.120.316101. Epub 2020 May 21. Erratum In: Circ Res. 2020 Jul 17;127(3):e107. — View Citation

Vecchie A, Dallegri F, Carbone F, Bonaventura A, Liberale L, Portincasa P, Fruhbeck G, Montecucco F. Obesity phenotypes and their paradoxical association with cardiovascular diseases. Eur J Intern Med. 2018 Feb;48:6-17. doi: 10.1016/j.ejim.2017.10.020. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To examine the association between different obesity phenotypes and cardiovascular by using lipid profile and echocardiography Using echocardiography and lipid profile to determine the relationship between obesity and cardiovascular diseases in obese and non obese people One year
Primary Assess carotid artery elasticity in obese by using echocardiography Find out the effect of cardiovascular diseases and obesity on carotid artery elasticity and atherosclerosis One year
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