Clinical trial NCT03126240: The Role of Sleeve Gastrectomy in Dyslpidemia
Official title: The Role of Sleeve Gastrectomy in Dyslpidemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty obese patients with an abnormal lipid profile not responding to conservative management will be enrolled in this study

Brief summary: The increasing prevalence of obesity noticed in recent decades is a major public health problem of pandemic nature. According to researches, there will be 2.3 billion overweight adults and more than 700 million people suffering from obesity worldwide by the year 2020.Series of epidemiologic studies has revealed a relative link between morbid obesity and metabolic syndrome type 2 diabetes mellitus, hypertension, hyperlipidemia, insulin resistance and shorter life span. Dyslipidemia specially when combined with obesity significantly increase the incidence of atherosclerosis and its complications and also insulin resistance and hence control of diabetic patients. Hyperlipidemia is widely recognized as one of the main co- morbidities in severe obesity and major risk factor for development of atherosclerosis and then heart related diseases.Bariatric surgery has become a prominent treatment modality after the rapidly increasing prevalence of obesity.

Detailed description: The increasing prevalence of obesity noticed in recent decades is a major public health problem of pandemic nature. According to researches, there will be 2.3 billion overweight adults and more than 700 million people suffering from obesity worldwide by the year 2020.Series of epidemiologic studies has revealed a relative link between morbid obesity and metabolic syndrome type 2 diabetes mellitus, hypertension, hyperlipidemia, insulin resistance and shorter life span. Dyslipidemia specially when combined with obesity significantly increase the incidence of atherosclerosis and its complications and also insulin resistance and hence control of diabetic patients. Hyperlipidemia is widely recognized as one of the main co- morbidities in severe obesity and major risk factor for development of atherosclerosis and then heart related diseases\[5-6\].Bariatric surgery has become a prominent treatment modality after the rapidly increasing prevalence of obesity.

Surgical treatment of higher obesity levels is the most effective procedure due to its simple technique and lower complications with the best outcomes in a long-term perspective. Dramatic weight loss leads to improvement of associated co-morbidities as well. Laparoscopic sleeve gastrectomy leads to long-term weight and improvement or resolution of hypertension, diabetes mellitus type2 and hyperlipidemia.

Studies reported resolution of hypertension in 58% and resolution or improvement of hypertension in 75% of patients following sleeve gastrectomy , resolution of type 2 diabetes mellitus in 84 % of patients as well.

Omana et al. found a greater resolution or improvement of hyperlipidemia with LSG. Hyperlipidemia improved in 87% of patients after LSG.

According to a previous series of studies done before ( 26 studies ) , 11 reported both resolution and improvement of dyslipidemia after LSG and 83.5% of the patients had experienced resolution or improvement of dyslipidemia. Another 7 studies reported only hyperlipidemia resolution and 54% of patients had complete resolution of hyperlipidemia. One study reported improvement of hyperlipidemia in 42% of the patients.

Five studies compared the lipid profile results pre and post-surgery. Only three studies showed minimal changes between pre and post operative cholesterol and LDL levels. However, the same three studies reported significant changes in triglyceride level and HDL level post LSG

Eligibility criteria: Inclusion Criteria:

* Have BMI \> 40
* Have BMI \> 35 with co-morbidities.
* Signed a well informed and signed written consent.
* Patients with abnormal lipid profile
* Patients failed in trials of conservative management including dietary control regarding lipid profile

Exclusion Criteria:

* Endocrine disease
* Severe uncontrolled heart disease
* Inability to follow instruction
* Drug abuse, and cancer

Primary outcomes:
measure: Low density lipoprotein
timeFrame: at 6 months postoperative
Secondary outcomes:
measure: Low density lipoprotein
timeFrame: at 1 year postoperative
measure: Total cholesterol level
timeFrame: at 6 months postoperative
measure: Total cholesterol level
timeFrame: at 1 year postoperative
measure: High density lipoprotein
timeFrame: at 6 months postoperative
measure: High density lipoprotein
timeFrame: at 1 year postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Specialist
name: Ahmed Mohie Eldin, MBBC
role: PRINCIPAL_INVESTIGATOR
References: