Clinical trial NCT06092021: Obesity Phenotypes and Its Relation to Cardiovascular Diseases
Official title: Obesity Phenotypes and Its Relation to Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Cardiovascular Diseases
Keywords: Cardiovascular diseases
Obesity phenotypes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Different obesity phenotypes people Accor to body mass index, waist circumference, waist hip ratio ,and metabolic profiles

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To examine the association between different obesity phenotypes and cardiovascular by using lipid profile and echocardiography
timeFrame: One year
measure: Assess carotid artery elasticity in obese by using echocardiography
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Asmaa khaled sayed
Study officials:
affiliation: Assiut University
name: Asmaa Sayed, Resident
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.