ObesityNCT05690139
Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Nutritional Status
An observational study of Obesity and Bariatric Surgery Candidate, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Healthy Eating Index
- What is being tested?
- Pre-operative LSG patients, Post-operative patients 1st month and Post-operative patients 3rd month
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteCyprus
- Study dates
- 6 Jul 2020to 6 Dec 2022
- 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: The population of the study consists of patients who received LSG surgery approval which was conducted in a special obesity clinic, Obezite Cerrahi Ankara Merkezi in Ankara, Turkey. The decision for surgery was taken after a multidisciplinary meeting, following recommendations of international consensus conferences or expert panels American Society for Metabolic and Bariatric Surgery (ASMBS).
Who may be able to join
- Volunteering to participate in the research,
- To have sleeve gastrectomy surgery,
- To be over 18 and under 65 years old
- Not having a perception disorder and communication problems
Who cannot join
- Ages <18 or >65 years old
- Having a pacemaker (implantation) or any prosthesis (inconvenient for segmental body analysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Protein-energy and Food Groups Consumption by Three Factors Eating Scale and Healthy Eating Index
Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.
Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included. Macro-micronutrient intake analysis, biochemical blood parameters, and anthropometric measures were performed before and 1, 3 and 6 months after LSG.
Read the detailed description
Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. Nutritional deficiencies are identified as the possible complications of bariatric surgery. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.
Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included in this study. Preoperative and postoperative (1, 3 and 6th months) protein-energy and other nutrient consumptions, eating habits, food consumption diversity were evaluated with food frequency questionnaire, 3-days food diary record, three-factor eating scale and healthy eating index. Also in the pre- and postoperative period; anthropometric (weight, height, waist, hip, fat free mass) values measured and biochemical blood parameters were collected.
- Conditions
- Obesity, Bariatric Surgery Candidate, Healthy Eating Index
- Being tested
- Pre-operative LSG patients, Post-operative patients 1st month, Post-operative patients 3rd month, Post-operative patients 6th month
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative LSG patientsProcedure or surgery
Baseline
Post-operative patients 1st monthProcedure or surgery
1 month after surgery
Post-operative patients 3rd monthProcedure or surgery
3 months after surgery
Post-operative patients 6th monthProcedure or surgery
6 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Obese patients received LSG surgery approval Receives: Procedure: Pre-operative LSG patients; Procedure: Post-operative patients 1st month; Procedure: Post-operative patients 3rd month; Procedure: Post-operative patients 6th month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months)
Daily nutrient intake was calculated by using computer software (Stuttgart, Germany; Turkish version: BeBiS, Vers. 9)
Measured: 6 months
Three Factor Eating Questionnaire Revised-21 (TFEQ-Tr21) scale
Dietary Behavior: A modification of the Three Factor Eating Questionnaire (TFEQ-TR21) was used to assess cognitive restraint of eating, disinhibition, and hunger.
Measured: 6 months
Healthy Eating Index (HEI-2010)
Diet Quality: was assessed using the HEI-2010, a measure of diet quality that assesses how well dietary intake aligns with key recommendations.
Measured: 6 months
Secondary outcomes (6)
Comparing the waist circumference (cm) of all interventions
after the pre and post operative intervention waist circumferences (midway between the rib cage and the iliac crest) were measured using a flexible tape.
Measured: 6 months
Comparing the body mass index (BMI) of all interventions
BMI was calculated (weight/height squared; in kilograms per square meter)
Measured: 6 months
Comparing the body fat percentage (%) of all interventions
the percentage of body fat and fat free mass (FFM) was measured by Tanita Segmental Body Composition Analyzer MC-780MA-N.
Measured: 6 months
Comparing the fasting blood glucose levels of all interventions
Concentration of fasting blood glucose levels baseline and changes after 1,3 and 6 months after surgery were compared. Blood samples were obtained from medical files before surgery and after 1,3,6 months of surgery period, and sera were stored at -30∘ C, until analytical measurements were performed.
Measured: 6 months
Comparing the serum lipid levels of all interventions
Differences in concentration of serum lipid levels of participants in baseline period and after post-operation were measured.
Blood samples were obtained from medical files at baseline period (pre-operation) and after each intervention period (post-operation 1.3.6 months), and sera were stored at -30∘ C, until analytical measurements were performed. The levels of serum lipids: Triglycerides (mg/dL), Total cholesterol (mg/dL), and HDL cholesterol (mg/dL) were determined using a Dimension Xpand Plus integrated clinical chemistry autoanalyzer (Siemens Healthcare Diagnostics, USA).
Measured: 6 months
Comparing the serum B12 levels of all interventions
baseline, 1,3,6, months after surgery B12 blood measurements taken from patients medical files.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start6 Jul 2020
- Primary completion6 Jul 2021
- Study completion6 Dec 2022
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sema Erge, Asst. Prof., Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690139
- Sponsor's protocol ID
- ETK00-2020-0168
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Protein-energy and Food Groups Consumption by Three Factors Eating Scale and Healthy Eating Index
- ClinicalTrials.gov ID
- NCT05690139
- Acronym / sponsor ID
- ETK00-2020-0168
- Conditions
- Obesity, Bariatric Surgery Candidate, Healthy Eating Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 19 Jan 2023 (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.
Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.
Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included. Macro-micronutrient intake analysis, biochemical blood parameters, and anthropometric measures were performed before and 1, 3 and 6 months after LSG.
Detailed description
Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. Nutritional deficiencies are identified as the possible complications of bariatric surgery. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.
Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included in this study. Preoperative and postoperative (1, 3 and 6th months) protein-energy and other nutrient consumptions, eating habits, food consumption diversity were evaluated with food frequency questionnaire, 3-days food diary record, three-factor eating scale and healthy eating index. Also in the pre- and postoperative period; anthropometric (weight, height, waist, hip, fat free mass) values measured and biochemical blood parameters were collected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Procedure: Pre-operative LSG patients, Procedure: Post-operative patients 1st month, Procedure: Post-operative patients 3rd month, Procedure: Post-operative patients 6th monthObese patients received LSG surgery approval |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consists of patients who received LSG surgery approval which was conducted in a special obesity clinic, Obezite Cerrahi Ankara Merkezi in Ankara, Turkey. The decision for surgery was taken after a multidisciplinary meeting, following recommendations of international consensus conferences or expert panels American Society for Metabolic and Bariatric Surgery (ASMBS).
Key inclusion criteria (4 listed)
- Volunteering to participate in the research,
- To have sleeve gastrectomy surgery,
- To be over 18 and under 65 years old
- Not having a perception disorder and communication problems
Key exclusion criteria (2 listed)
- Ages <18 or >65 years old
- Having a pacemaker (implantation) or any prosthesis (inconvenient for segmental body analysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative LSG patientsBaseline | Procedure or surgery | Obese patients |
| Post-operative patients 1st month1 month after surgery | Procedure or surgery | Obese patients |
| Post-operative patients 3rd month3 months after surgery | Procedure or surgery | Obese patients |
| Post-operative patients 6th month6 months after surgery | Procedure or surgery | Obese patients |
Primary outcome
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months)
Time frame: 6 months
Daily nutrient intake was calculated by using computer software (Stuttgart, Germany; Turkish version: BeBiS, Vers. 9)
Three Factor Eating Questionnaire Revised-21 (TFEQ-Tr21) scale
Time frame: 6 months
Dietary Behavior: A modification of the Three Factor Eating Questionnaire (TFEQ-TR21) was used to assess cognitive restraint of eating, disinhibition, and hunger.
Healthy Eating Index (HEI-2010)
Time frame: 6 months
Diet Quality: was assessed using the HEI-2010, a measure of diet quality that assesses how well dietary intake aligns with key recommendations.
6 secondary outcomes
Comparing the waist circumference (cm) of all interventions
Time frame: 6 months
Comparing the body mass index (BMI) of all interventions
Time frame: 6 months
Comparing the body fat percentage (%) of all interventions
Time frame: 6 months
Comparing the fasting blood glucose levels of all interventions
Time frame: 6 months
Comparing the serum lipid levels of all interventions
Time frame: 6 months
Comparing the serum B12 levels of all interventions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- 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.
Sema Erge, Asst. Prof. study chair
Eastern Mediterranean 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 Obesity and Bariatric Surgery Candidate, run by Eastern Mediterranean University at 1 site in Cyprus.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jan 2023. 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 Cyprus. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 19 Jan 2023.