ObesityNCT03126240
The Role of Sleeve Gastrectomy in Dyslpidemia
An observational study of Obesity, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Twenty obese patients with an abnormal lipid profile not responding to conservative management will be enrolled in this study
Who may be able to join
- 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
Who cannot join
- Endocrine disease
- Severe uncontrolled heart disease
- Inability to follow instruction
- Drug abuse, and cancer
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein
lipid profile
Measured: at 6 months postoperative
Secondary outcomes (5)
Low density lipoprotein
lipid profile
Measured: at 1 year postoperative
Total cholesterol level
lipid profile
Measured: at 6 months postoperative
Total cholesterol level
lipid profile
Measured: at 1 year postoperative
High density lipoprotein
lipid profile
Measured: at 6 months postoperative
High density lipoprotein
lipid profile
Measured: at 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohie Eldin, Assiut University
- Investigators
- Ahmed Mohie Eldin, MBBC, Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126240
- Sponsor's protocol ID
- sleeveindyslipedemia
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleeve Gastrectomy in Dyslpidemia
- ClinicalTrials.gov ID
- NCT03126240
- Acronym / sponsor ID
- sleeveindyslipedemia
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Twenty obese patients with an abnormal lipid profile not responding to conservative management will be enrolled in this study
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Endocrine disease
- Severe uncontrolled heart disease
- Inability to follow instruction
- Drug abuse, and cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Low density lipoprotein
Time frame: at 6 months postoperative
lipid profile
5 secondary outcomes
Low density lipoprotein
Time frame: at 1 year postoperative
Total cholesterol level
Time frame: at 6 months postoperative
Total cholesterol level
Time frame: at 1 year postoperative
High density lipoprotein
Time frame: at 6 months postoperative
High density lipoprotein
Time frame: at 1 year postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohie Eldin, MBBC principal investigator
Specialist
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohie Eldin, MBBC (+201062233321, ahmed_mohie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density lipoprotein (time frame: at 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.