Morbid ObesityNCT02193529
Dietary Intake After Laparoscopic Sleeve Gastrectomy -a 5 Year Study
An observational study of Morbid Obesity, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial summary
Weight reducing surgery is the only effective therapy for morbid obese patients. Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There is poor knowledge about the nutritional status inpatients after LSG. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years. BMI above 40 kg/m2 when operation. Age 18-65 years old.
Who may be able to join
- morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years.
- BMI above 40 kg/m2 when operation. Age 18-65 years old. No major psychosis or binge eating disorder. No endocrine disease. failed to lose weight with medical therapy.
Who cannot join
- current hepatitis, under steroid treatment,cancer, thyroid disease,alcoholism.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital
Taoyuan, Taoyuan, 330
Ju J Chou, university, 886933164297, n002434@e-ms.com.tw
Jung C Chen, university, 886933164297, jackykenzero@gmail.com
About this study
Official title: Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital
Weight reducing surgery is the only effective therapy for morbid obese patients.
Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.
Read the detailed description
Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is surgically removed by vertical resection of the great curvature side, including the fundus. The simplicity of surgical procedures, the low occurrence of complications, and the efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery. After LSG, the amount of food eaten is drastically reduced, leading to nutritional deficiencies potentially. There is poor knowledge about the nutritional status inpatients after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.
- Conditions
- Morbid Obesity
- Keywords
- sleeve gastrectomy, dietary intake, morbid obesity.
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake after laparoscopic sleeve gastrectomy 5 years
The aim of this study was to investigate the relationship between dietary intake and weight loss effect after sleeve gastrectomy.The calculation of the majority of the nutrients is based on Australian nutrient composition data. The item include: energy ( kcal/day), protein, fat, carbohydrate, vitamin and minerals.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI-CHENG YAO, Min-Sheng General Hospital
- Investigators
- Ju J Chou, university, Principal investigator, School of Nutrition and Health Sciences,Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193529
- Sponsor's protocol ID
- DIA-LSG
- Other IDs
- DIA5y
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital
- ClinicalTrials.gov ID
- NCT02193529
- Acronym / sponsor ID
- DIA-LSG
- Conditions
- Morbid Obesity
- Keywords
- sleeve gastrectomy, dietary intake, morbid obesity.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Jul 2014 (estimated)
- 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.
Weight reducing surgery is the only effective therapy for morbid obese patients.
Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.
Detailed description
Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is surgically removed by vertical resection of the great curvature side, including the fundus. The simplicity of surgical procedures, the low occurrence of complications, and the efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery. After LSG, the amount of food eaten is drastically reduced, leading to nutritional deficiencies potentially. There is poor knowledge about the nutritional status inpatients after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years. BMI above 40 kg/m2 when operation. Age 18-65 years old.
Key inclusion criteria (2 listed)
- morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years.
- BMI above 40 kg/m2 when operation. Age 18-65 years old. No major psychosis or binge eating disorder. No endocrine disease. failed to lose weight with medical therapy.
Key exclusion criteria (1 listed)
- current hepatitis, under steroid treatment,cancer, thyroid disease,alcoholism.
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
Dietary intake after laparoscopic sleeve gastrectomy 5 years
Time frame: up to 18 months
The aim of this study was to investigate the relationship between dietary intake and weight loss effect after sleeve gastrectomy.The calculation of the majority of the nutrients is based on Australian nutrient composition data. The item include: energy ( kcal/day), protein, fat, carbohydrate, vitamin and minerals.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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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.
Ju J Chou, university principal investigator
School of Nutrition and Health Sciences,Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Min-Sheng General Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ju J Chou, university (886933164297, n002434@e-ms.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intake after laparoscopic sleeve gastrectomy 5 years (time frame: up to 18 months). 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 17 Jul 2014.