CClinicalTrials.gg
Status unknownNCT03126240Updated Apr 24, 2017

The Role of Sleeve Gastrectomy in Dyslpidemia

An observational study in Obesity, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • Endocrine disease
  • Severe uncontrolled heart disease
  • Inability to follow instruction
  • Drug abuse, and cancer
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • sleeve Gastrectomy

    This is a five-trocar technique. The abdominal cavity is accessed through a 1cm supraumbilical incision using an optical trocar. The operating ports are inserted under direct vision. The gastroesophageal (GE) junction is exposed. A point on the greater curvature approximately 3-6cm to the pylorus is identified as the distal extent of the resection. Ultrasonic shears are used to divide the vessels long the greater curve up to the angle of His. Linear cutting staplers are used to vertically transect the stomach, creating a narrow gastric tube with. A 19Fr drain is placed in the subhepatic space near the staple line. The resected portion of the stomach is extracted through one of the working ports.

06

What researchers measure

Primary outcomes

  1. Low density lipoprotein

    lipid profile

    Time frame: at 6 months postoperative

Secondary outcomes

  1. Low density lipoprotein

    lipid profile

    Time frame: at 1 year postoperative

  2. Total cholesterol level

    lipid profile

    Time frame: at 6 months postoperative

  3. Total cholesterol level

    lipid profile

    Time frame: at 1 year postoperative

  4. High density lipoprotein

    lipid profile

    Time frame: at 6 months postoperative

  5. High density lipoprotein

    lipid profile

    Time frame: at 1 year postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03126240
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Mohie Eldin (Doctor, Assiut University) — Principal investigator
First posted
Apr 24, 2017
Start date
Jun 1, 2017 (estimated)
Primary completion
May 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Apr 24, 2017

Study contacts

Ahmed Mohie Eldin, MBBC
Contact
ahmed_mohie@hotmail.com
+201062233321
Ahmed Mohie Eldin, MBBC
principal investigator · Specialist

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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