Bariatric SurgeryNCT04200521
The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
An observational study of Bariatric Surgery and Microbiota, run by Zayed University at 2 sites in 2 countries.
Trial summary
Overweight and obesity are worldwide health problems that can affect negatively quality of life. With increasing prevalence of obesity and the failure of compliance to lifestyle, bariatric surgeries have become the treatment of choice to help achieve long term sustainable weight loss. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Microbiota, Obesity
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Oct 2019to Oct 2020
- How long will I take part?
- 3 Months
- 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
- Healthy volunteers accepted
- Adult
Study population: Forty Emirati obese adults from UAE and 40 Lebanese obese adults from Lebanon from both genders and planning to undergo bariatric procedure (irrelevant of the study) will be recruited. All participants planning to conduct the surgery will be contacted, the consenting ones will be recruited till target sample saturation. Afterwards, 40 healthy counterparts from each country will be selected. Healthy participants can be employees from Qassimi HospitaI in sharjah and Middle East Institute of Health University Hopsital in Lebanon or any healthy Emirati and Lebanese people willing to participate in the study.
Who may be able to join
- Emirati residing in UAE and Lebanese residing in Lebanon
- 18 to 60 years old - from both genders
- Free of antibiotics for at least 3 months
- Two BMI categories: 1) obese with a BMI of ≥35 kg/m2 planning to undergo a bariatric procedure 2) healthy counterparts with a BMI of 18.5-24.9 kg/m2
Who cannot join
- Individuals who do not meet the inclusion criteria
- Consumption of alcohol above the recommended amount per day (>½ ounce of ethanol for females and >1 ounce for men)
- Pregnant at the time of the study
- Significant voluntary weight loss (≥5% in the preceding 3 months)
- Not willing to provide written consent to the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Lebanon1 site, 1 recruiting
- Not yet recruiting
Middle East Institute of Health, University Hospital
Beirut
Murielle Abou samra, 009614714583, mja12@aub.edu.lb
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Qassimi Hospital
Sharjah city
tarek Mahdi, Doctor, 00971507601644, tmahdi@yahoo.com
About this study
Official title: The Effect of Bariatric Procedures on Gut Microbiota, Gut Peptide and Metabolism in Obese Individuals in United Arab Emirates and Lebanon
Overweight and obesity are worldwide health problems that can affect negatively quality of life. With increasing prevalence of obesity and the failure of compliance to lifestyle, bariatric surgeries have become the treatment of choice to help achieve long term sustainable weight loss. In some cases of bariatric surgery, weight loss stops and there are cases in which obesity manifests itself again; the mechanism underlying the re-appearance of obesity is not known. Recently, the gut microbiota, has been implicated in the etiology of obesity and metabolic syndrome due to its important role in digestion, metabolism and regulating gut peptides and hormones. In accordance with this, it has been shown in mice that obesity can be associated with dysbiosis (Imbalance in gut bacteria) and there has been successful reduction of weight in interventions when microbiota was manipulated.
Hypothesis:
Read more
- Emirati participants will have unique microbiota and gut peptides when compared to Lebanese participants.
- The microbiota and gut peptides variability is significantly different between those with normal weight compared to obese participants undergoing bariatric surgery.
- The bariatric procedure will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism among the obese participants.
Objectives of the study:
- Determine the gut microbiota composition of Emirati healthy normal weight participants and compare to that of Lebanese via Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.
- Determine the gut microbiota composition of Emirati obese participants and compare to that of Lebanese counterparts using NGS.
- Determine the effect of bariatric procedure in UAE and Lebanon respectively on gut microbiota (using NGS), gut peptides in plasma, blood chemistry and metabolism using indirect calorimetry and food intake.
Importance of this research:
The microbiota and gut peptides variability is determined by body weight and ethnicity of the studied populations. It is hypothesized that bariatric surgery will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism. This study will be a pioneering research in UAE and Lebanon to assist in finding population tailored therapeutic strategies that target the gut microbiota and treat obesity.
Read the detailed description
This study has two arms: 1) cross-sectional observation on healthy participants, and 2) multi-center, prospective study of 3 month duration (pre and post design) on obese participants undergoing bariatric procedure.
Population study: Forty Emirati obese adults from UAE and 40 Lebanese obese adults from Lebanon from both genders and planning to undergo bariatric procedure (irrelevant of the study) will be recruited. All participants planning to conduct the surgery will be contacted; the consenting ones will be recruited till target sample saturation. Afterwards, 40 healthy counterparts from each country will be selected. Healthy participants will be recruited from Zayed University or staff of Qassimi Hospital in Sharjah, UAE and from staff/students/colleagues of the Middle East Institute of Health University Hopsital in Lebanon.
Assessment and Data Collection: 2 Research assistants (one in each hospital) will be trained by the principal investigator (PI) on the study instruments and data collection methods. These assistants will administer 4 questionnaires for each participant (healthy and obese per-operatively) at baseline(t0) and 4 questionnaires for the obese participants after the bariatric procedure after 3 months (t1). For quality control purposes, each questionnaire will be administered to all patients before the administration of the following questionnaire. Furthermore, each questionnaire will be completed and reviewed prior to administering the next. The assessment will take place in the specified clinic or hospital.
All of the parameters, except the demographics and initial screening questionnaire (collected only at t0) and follow up post bariatric questionnaire (t1: at 3 months, after the bariatric procedure), will be collected and monitored at 2 time points: Baseline (t0: at the beginning of the study), and follow up for obese participants (t1: at 3 months, after the bariatric procedure).
Assessment tools include:
Demographics
Questionnaires for:
- Initial screening questionnaire ii. Follow up post bariatric questionnaire iii. 24 hour recall iv. Anxiety and Stress Levels using the DASS v. Appetite questionnaire
All questionnaires that are originally not in Arabic, will be translated to Arabic (local language), prior to study by translators whose first language is Arabic and back translated to English to assure coherence with original version.
Biochemical evaluation
An overnight fast of at least 12 h for blood collection is required. Collection will be done by a certified nurse at the Middle East institute of Health University Hospital and Qassimi Hospital. The blood will be analyzed for the following parameters:
- Lipid and glucose profile: serum triglyceride, total cholesterol, HDL-cholesterol, LDL- cholesterol, fasting blood glucose,
- Gut peptides: Total GLP-1, GLP-2, PYY, CCK, Ghrelin,
- Hormones: fasting insulin and Leptin
The questionnaires will be administered during the participants' routine visits. And blood draw will be taken during that visit (for obese participants,around 1 week prior to surgery) And 3 months post bariatric surgery for obese individuals. For each time, for the complete process, a total of 30 min will be needed per participant.
Nutritional Assessment • Anthropometric measurements will be assessed through a dietitian at the Middle East institute of Health University Hospital in Lebanon and Qassimi Hospital in sharjah, UAE. It will include body weight, body height, Body mass index (BMI), waist circumference (WC). Body composition will be evaluated using bioelectrical impedance analysis and energy expenditure using portable Indirect Calorimeter.
Fecal microbiota analysis.
- Participants will be given special collection kits followed by instructions on how to collect the stool. They will be asked to inform the research team when the samples are ready, so it will be collected within 24 hours. 2 samples will be collected from each participant, where 1 will be analyzed and second kept for accuracy check. Stool microbiota analysis will be done for all the participants at baseline and repeated at 3 months for the obese participants post bariatric surgery. Using Polymerase Chain Reaction (PCR) products of the V3-V4 region of 16S rRNA gene will be sequenced using a barcoded Illumina paired-end sequencing technique. The primary composition of the microbiome in the stool samples will be determined and analyzed by cluster analysis.
Sample size was determined according to change in Bacteroidetes/Firmicutes ratio, considering it as the main objective outcome of this study. Calculations were based on the data retrieved from Damms-Machado et al (2015) where serum Bacteroidetes/Firmicutes ratio changed significantly from 5.9 ±2.1 to 10.4± 1.4 in 3 months post bariatric surgery.To generate a similar significant effect of a sample size of 2 participants was estimated to achieve 80% power at a 5% alpha. Expecting a drop in effect size in this protocol, a high attrition rate among the samples at 3 months; we multiplied the number of participants in it by 20. Thus a sample of 40 participants per groups was planned for this study.
Data will be analyzed through SPSS version 18. Correlations will be conducted through ANOVA. Effect of the study will be analyzed by paired t test on continuous data and Chi square on categorical data. Microbiota composition will be analyzed using QIIME, and alpha- and beta-diversity will be determined.
- Conditions
- Bariatric Surgery, Microbiota, Obesity, Dysbiosis
- Keywords
- Gut peptide, Energy metabolism, Appetite
- Medical subject headings
- Obesity, Dysbiosis
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 |
|---|---|---|
| Healthy weight individuals | Cross-sectional observation on healthy participants who will be recruited from the general population from both genders (Lebanese and Emirati Subjects). | |
| Obese individuals | Prospective study of 3 months duration (pre and post design) on obese Emirati and Lebanese participants undergoing bariatric procedure irrelevant of the study, from Qassimi Hospital In sharja and Middle East Institute of Health University Hospital, Lebanon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut Microbiota composition in obese participants
Using Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.
Measured: Baseline and 3 months post bariatric surgery
Secondary outcomes (14)
Changes in plasma level of CCK Hormone in obese participants
Via Blood test
Measured: Baseline and 3 months post bariatric surgery
Changes in plasma level of PYY Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of Ghrelin Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of Leptin Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of Insulin Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of GLP1 Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of GLP2 Hormone in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of fasting Cholesterol in obese participants
Via Blood test
Measured: Baseline and 3 month post bariatric surgery
Changes in plasma level of Fasting Blood Sugar in obese participants
Using Blood test
Measured: Baseline and 3 month post bariatric surgery
Assessing changes in Energy Expenditure in obese participants
By using Indirect Calorimeter
Measured: Baseline and 3 months post bariatric surgery
Assessing changes in appetite in obese participants
Using Simplified Nutritional Appetite Questionnaire. Following numerical scale: a =1, b =2, c = 3, d =4, e = 5. The sum of the scores for the individual items constitutes the SNAQ score. SNAQ score 14 indicates significant risk of at least 5% weight loss within six months.
Measured: Baseline and 3 months post bariatric surgery
Changes in Dietary Intake in obese participants
Using 24 Hour dietary recall method. The method consists of precisely recalling, describing and quantifying the intake of foods and beverages consumed in the 24 hour period.
Measured: Baseline and 3 months post bariatric surgery
Measure the changes in emotional states of Depression, Anxiety and Stress.in obese participants
Using Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items.
Measured: Baseline and 3 months post bariatric surgery
Changes in Body Composition in obese participants
Via Bio-electrical Impedance Analysis
Measured: Baseline and 3 months post bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start27 Oct 2019
- Primary completionMay 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zayed University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirey Karavetian, Zayed University
- Investigators
- Mirey Karavetian, PhD, Principal investigator, Zayed University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200521
- Sponsor's protocol ID
- 1234
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lovibond, S.H. & Lovibond, P.F. Manual for the Depression Anxiety & Stress Scales. (2nd Ed.)Sydney. Psychology Foundation 1995.
Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.
PubMed 25710027Cannon CP, Kumar A. Treatment of overweight and obesity: lifestyle, pharmacologic, and surgical options. Clin Cornerstone. 2009;9(4):55-68; discussion 69-71. doi: 10.1016/s1098-3597(09)80005-7.
PubMed 19789064Seganfredo FB, Blume CA, Moehlecke M, Giongo A, Casagrande DS, Spolidoro JVN, Padoin AV, Schaan BD, Mottin CC. Weight-loss interventions and gut microbiota changes in overweight and obese patients: a systematic review. Obes Rev. 2017 Aug;18(8):832-851. doi: 10.1111/obr.12541. Epub 2017 May 19.
PubMed 28524627Aydin S. Can Peptides and Gut Microbiota Be Involved in the Etiopathology of Obesity? Obes Surg. 2017 Jan;27(1):202-204. doi: 10.1007/s11695-016-2429-0. No abstract available.
PubMed 27787759Bauer PV, Hamr SC, Duca FA. Regulation of energy balance by a gut-brain axis and involvement of the gut microbiota. Cell Mol Life Sci. 2016 Feb;73(4):737-55. doi: 10.1007/s00018-015-2083-z. Epub 2015 Nov 5.
PubMed 26542800Cani PD, Osto M, Geurts L, Everard A. Involvement of gut microbiota in the development of low-grade inflammation and type 2 diabetes associated with obesity. Gut Microbes. 2012 Jul-Aug;3(4):279-88. doi: 10.4161/gmic.19625. Epub 2012 May 14.
PubMed 22572877Corfe BM, Harden CJ, Bull M, Garaiova I. The multifactorial interplay of diet, the microbiome and appetite control: current knowledge and future challenges. Proc Nutr Soc. 2015 Aug;74(3):235-44. doi: 10.1017/S0029665114001670. Epub 2015 Jan 23.
PubMed 25612669Patrone V, Vajana E, Minuti A, Callegari ML, Federico A, Loguercio C, Dallio M, Tolone S, Docimo L, Morelli L. Postoperative Changes in Fecal Bacterial Communities and Fermentation Products in Obese Patients Undergoing Bilio-Intestinal Bypass. Front Microbiol. 2016 Feb 23;7:200. doi: 10.3389/fmicb.2016.00200. eCollection 2016.
PubMed 26941724Round JL, Mazmanian SK. The gut microbiota shapes intestinal immune responses during health and disease. Nat Rev Immunol. 2009 May;9(5):313-23. doi: 10.1038/nri2515.
PubMed 19343057Adlerberth I, Wold AE. Establishment of the gut microbiota in Western infants. Acta Paediatr. 2009 Feb;98(2):229-38. doi: 10.1111/j.1651-2227.2008.01060.x.
PubMed 19143664Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. doi: 10.1093/ajcn/82.5.1074.
PubMed 16280441
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bariatric Procedures on Gut Microbiota, Gut Peptide and Metabolism in Obese Individuals in United Arab Emirates and Lebanon
- ClinicalTrials.gov ID
- NCT04200521
- Acronym / sponsor ID
- 1234
- Conditions
- Bariatric Surgery, Microbiota, Obesity, Dysbiosis
- Keywords
- Gut peptide, Energy metabolism, Appetite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zayed UniversityUniversity, hospital or other
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Dec 2019 (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.
Overweight and obesity are worldwide health problems that can affect negatively quality of life. With increasing prevalence of obesity and the failure of compliance to lifestyle, bariatric surgeries have become the treatment of choice to help achieve long term sustainable weight loss. In some cases of bariatric surgery, weight loss stops and there are cases in which obesity manifests itself again; the mechanism underlying the re-appearance of obesity is not known. Recently, the gut microbiota, has been implicated in the etiology of obesity and metabolic syndrome due to its important role in digestion, metabolism and regulating gut peptides and hormones. In accordance with this, it has been shown in mice that obesity can be associated with dysbiosis (Imbalance in gut bacteria) and there has been successful reduction of weight in interventions when microbiota was manipulated.
Hypothesis:
- Emirati participants will have unique microbiota and gut peptides when compared to Lebanese participants.
- The microbiota and gut peptides variability is significantly different between those with normal weight compared to obese participants undergoing bariatric surgery.
- The bariatric procedure will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism among the obese participants.
Objectives of the study:
- Determine the gut microbiota composition of Emirati healthy normal weight participants and compare to that of Lebanese via Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.
- Determine the gut microbiota composition of Emirati obese participants and compare to that of Lebanese counterparts using NGS.
- Determine the effect of bariatric procedure in UAE and Lebanon respectively on gut microbiota (using NGS), gut peptides in plasma, blood chemistry and metabolism using indirect calorimetry and food intake.
Importance of this research:
The microbiota and gut peptides variability is determined by body weight and ethnicity of the studied populations. It is hypothesized that bariatric surgery will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism. This study will be a pioneering research in UAE and Lebanon to assist in finding population tailored therapeutic strategies that target the gut microbiota and treat obesity.
Detailed description
This study has two arms: 1) cross-sectional observation on healthy participants, and 2) multi-center, prospective study of 3 month duration (pre and post design) on obese participants undergoing bariatric procedure.
Population study: Forty Emirati obese adults from UAE and 40 Lebanese obese adults from Lebanon from both genders and planning to undergo bariatric procedure (irrelevant of the study) will be recruited. All participants planning to conduct the surgery will be contacted; the consenting ones will be recruited till target sample saturation. Afterwards, 40 healthy counterparts from each country will be selected. Healthy participants will be recruited from Zayed University or staff of Qassimi Hospital in Sharjah, UAE and from staff/students/colleagues of the Middle East Institute of Health University Hopsital in Lebanon.
Assessment and Data Collection: 2 Research assistants (one in each hospital) will be trained by the principal investigator (PI) on the study instruments and data collection methods. These assistants will administer 4 questionnaires for each participant (healthy and obese per-operatively) at baseline(t0) and 4 questionnaires for the obese participants after the bariatric procedure after 3 months (t1). For quality control purposes, each questionnaire will be administered to all patients before the administration of the following questionnaire. Furthermore, each questionnaire will be completed and reviewed prior to administering the next. The assessment will take place in the specified clinic or hospital.
All of the parameters, except the demographics and initial screening questionnaire (collected only at t0) and follow up post bariatric questionnaire (t1: at 3 months, after the bariatric procedure), will be collected and monitored at 2 time points: Baseline (t0: at the beginning of the study), and follow up for obese participants (t1: at 3 months, after the bariatric procedure).
Assessment tools include:
Demographics
Questionnaires for:
- Initial screening questionnaire ii. Follow up post bariatric questionnaire iii. 24 hour recall iv. Anxiety and Stress Levels using the DASS v. Appetite questionnaire
All questionnaires that are originally not in Arabic, will be translated to Arabic (local language), prior to study by translators whose first language is Arabic and back translated to English to assure coherence with original version.
Biochemical evaluation
An overnight fast of at least 12 h for blood collection is required. Collection will be done by a certified nurse at the Middle East institute of Health University Hospital and Qassimi Hospital. The blood will be analyzed for the following parameters:
- Lipid and glucose profile: serum triglyceride, total cholesterol, HDL-cholesterol, LDL- cholesterol, fasting blood glucose,
- Gut peptides: Total GLP-1, GLP-2, PYY, CCK, Ghrelin,
- Hormones: fasting insulin and Leptin
The questionnaires will be administered during the participants' routine visits. And blood draw will be taken during that visit (for obese participants,around 1 week prior to surgery) And 3 months post bariatric surgery for obese individuals. For each time, for the complete process, a total of 30 min will be needed per participant.
Nutritional Assessment • Anthropometric measurements will be assessed through a dietitian at the Middle East institute of Health University Hospital in Lebanon and Qassimi Hospital in sharjah, UAE. It will include body weight, body height, Body mass index (BMI), waist circumference (WC). Body composition will be evaluated using bioelectrical impedance analysis and energy expenditure using portable Indirect Calorimeter.
Fecal microbiota analysis.
- Participants will be given special collection kits followed by instructions on how to collect the stool. They will be asked to inform the research team when the samples are ready, so it will be collected within 24 hours. 2 samples will be collected from each participant, where 1 will be analyzed and second kept for accuracy check. Stool microbiota analysis will be done for all the participants at baseline and repeated at 3 months for the obese participants post bariatric surgery. Using Polymerase Chain Reaction (PCR) products of the V3-V4 region of 16S rRNA gene will be sequenced using a barcoded Illumina paired-end sequencing technique. The primary composition of the microbiome in the stool samples will be determined and analyzed by cluster analysis.
Sample size was determined according to change in Bacteroidetes/Firmicutes ratio, considering it as the main objective outcome of this study. Calculations were based on the data retrieved from Damms-Machado et al (2015) where serum Bacteroidetes/Firmicutes ratio changed significantly from 5.9 ±2.1 to 10.4± 1.4 in 3 months post bariatric surgery.To generate a similar significant effect of a sample size of 2 participants was estimated to achieve 80% power at a 5% alpha. Expecting a drop in effect size in this protocol, a high attrition rate among the samples at 3 months; we multiplied the number of participants in it by 20. Thus a sample of 40 participants per groups was planned for this study.
Data will be analyzed through SPSS version 18. Correlations will be conducted through ANOVA. Effect of the study will be analyzed by paired t test on continuous data and Chi square on categorical data. Microbiota composition will be analyzed using QIIME, and alpha- and beta-diversity will be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy weight individuals | – | –Cross-sectional observation on healthy participants who will be recruited from the general population from both genders (Lebanese and Emirati Subjects). |
| Obese individuals | – | –Prospective study of 3 months duration (pre and post design) on obese Emirati and Lebanese participants undergoing bariatric procedure irrelevant of the study, from Qassimi Hospital In sharja and Middle East Institute of Health University Hospital, Lebanon |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Forty Emirati obese adults from UAE and 40 Lebanese obese adults from Lebanon from both genders and planning to undergo bariatric procedure (irrelevant of the study) will be recruited. All participants planning to conduct the surgery will be contacted, the consenting ones will be recruited till target sample saturation. Afterwards, 40 healthy counterparts from each country will be selected. Healthy participants can be employees from Qassimi HospitaI in sharjah and Middle East Institute of Health University Hopsital in Lebanon or any healthy Emirati and Lebanese people willing to participate in the study.
Key inclusion criteria (4 listed)
- Emirati residing in UAE and Lebanese residing in Lebanon
- 18 to 60 years old - from both genders
- Free of antibiotics for at least 3 months
- Two BMI categories: 1) obese with a BMI of ≥35 kg/m2 planning to undergo a bariatric procedure 2) healthy counterparts with a BMI of 18.5-24.9 kg/m2
Key exclusion criteria (5 listed)
- Individuals who do not meet the inclusion criteria
- Consumption of alcohol above the recommended amount per day (>½ ounce of ethanol for females and >1 ounce for men)
- Pregnant at the time of the study
- Significant voluntary weight loss (≥5% in the preceding 3 months)
- Not willing to provide written consent to the study
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
Changes in Gut Microbiota composition in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Using Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples.
14 secondary outcomes
Changes in plasma level of CCK Hormone in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Changes in plasma level of PYY Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of Ghrelin Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of Leptin Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of Insulin Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of GLP1 Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of GLP2 Hormone in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of fasting Cholesterol in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Changes in plasma level of Fasting Blood Sugar in obese participants
Time frame: Baseline and 3 month post bariatric surgery
Assessing changes in Energy Expenditure in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Assessing changes in appetite in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Changes in Dietary Intake in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Measure the changes in emotional states of Depression, Anxiety and Stress.in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Changes in Body Composition in obese participants
Time frame: Baseline and 3 months post bariatric surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- BackgroundLovibond, S.H. & Lovibond, P.F. Manual for the Depression Anxiety & Stress Scales. (2nd Ed.)Sydney. Psychology Foundation 1995.
- Background: PubMed 25710027Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.
- Results publication: PubMed 19789064Cannon CP, Kumar A. Treatment of overweight and obesity: lifestyle, pharmacologic, and surgical options. Clin Cornerstone. 2009;9(4):55-68; discussion 69-71. doi: 10.1016/s1098-3597(09)80005-7.
- Results publication: PubMed 28524627Seganfredo FB, Blume CA, Moehlecke M, Giongo A, Casagrande DS, Spolidoro JVN, Padoin AV, Schaan BD, Mottin CC. Weight-loss interventions and gut microbiota changes in overweight and obese patients: a systematic review. Obes Rev. 2017 Aug;18(8):832-851. doi: 10.1111/obr.12541. Epub 2017 May 19.
- Results publication: PubMed 27787759Aydin S. Can Peptides and Gut Microbiota Be Involved in the Etiopathology of Obesity? Obes Surg. 2017 Jan;27(1):202-204. doi: 10.1007/s11695-016-2429-0. No abstract available.
- Results publication: PubMed 26542800Bauer PV, Hamr SC, Duca FA. Regulation of energy balance by a gut-brain axis and involvement of the gut microbiota. Cell Mol Life Sci. 2016 Feb;73(4):737-55. doi: 10.1007/s00018-015-2083-z. Epub 2015 Nov 5.
- Results publication: PubMed 22572877Cani PD, Osto M, Geurts L, Everard A. Involvement of gut microbiota in the development of low-grade inflammation and type 2 diabetes associated with obesity. Gut Microbes. 2012 Jul-Aug;3(4):279-88. doi: 10.4161/gmic.19625. Epub 2012 May 14.
- Results publication: PubMed 25612669Corfe BM, Harden CJ, Bull M, Garaiova I. The multifactorial interplay of diet, the microbiome and appetite control: current knowledge and future challenges. Proc Nutr Soc. 2015 Aug;74(3):235-44. doi: 10.1017/S0029665114001670. Epub 2015 Jan 23.
- Results publication: PubMed 26941724Patrone V, Vajana E, Minuti A, Callegari ML, Federico A, Loguercio C, Dallio M, Tolone S, Docimo L, Morelli L. Postoperative Changes in Fecal Bacterial Communities and Fermentation Products in Obese Patients Undergoing Bilio-Intestinal Bypass. Front Microbiol. 2016 Feb 23;7:200. doi: 10.3389/fmicb.2016.00200. eCollection 2016.
- Results publication: PubMed 19343057Round JL, Mazmanian SK. The gut microbiota shapes intestinal immune responses during health and disease. Nat Rev Immunol. 2009 May;9(5):313-23. doi: 10.1038/nri2515.
- Results publication: PubMed 19143664Adlerberth I, Wold AE. Establishment of the gut microbiota in Western infants. Acta Paediatr. 2009 Feb;98(2):229-38. doi: 10.1111/j.1651-2227.2008.01060.x.
- Results publication: PubMed 16280441Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. doi: 10.1093/ajcn/82.5.1074.
- Individual participant dataSharing planned: No
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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.
Mirey Karavetian, PhD principal investigator
Zayed University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Microbiota, run by Zayed University at 2 sites in 2 countries.
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 5 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon, United Arab Emirates. 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 Mirey karavetian, PhD (+971562446865, Mirey.Karavetian@zu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut Microbiota composition in obese participants (time frame: Baseline and 3 months post bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200521, which also lists 12 linked publications.
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 16 Dec 2019.