The Effect of Bariatric Procedures on Gut Microbiota, Gut Peptide and Metabolism in Obese Individuals in United Arab Emirates and Lebanon
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Changes in Gut Microbiota composition in obese participants
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in Gut Microbiota composition in obese participants
时间窗: 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.
次要结局
- Changes in Dietary Intake in obese participants(Baseline and 3 months post bariatric surgery)
- Measure the changes in emotional states of Depression, Anxiety and Stress.in obese participants(Baseline and 3 months post bariatric surgery)
- Changes in plasma level of Leptin Hormone in obese participants(Baseline and 3 month post bariatric surgery)
- Changes in plasma level of GLP2 Hormone in obese participants(Baseline and 3 month post bariatric surgery)
- Changes in plasma level of Fasting Blood Sugar in obese participants(Baseline and 3 month post bariatric surgery)
- Assessing changes in Energy Expenditure in obese participants(Baseline and 3 months post bariatric surgery)
- Changes in Body Composition in obese participants(Baseline and 3 months post bariatric surgery)
- Changes in plasma level of Ghrelin Hormone in obese participants(Baseline and 3 month post bariatric surgery)
- Changes in plasma level of Insulin Hormone in obese participants(Baseline and 3 month post bariatric surgery)
- Changes in plasma level of GLP1 Hormone in obese participants(Baseline and 3 month post bariatric surgery)
- Assessing changes in appetite in obese participants(Baseline and 3 months post bariatric surgery)
- Changes in plasma level of CCK Hormone in obese participants(Baseline and 3 months post bariatric surgery)
- Changes in plasma level of fasting Cholesterol in obese participants(Baseline and 3 month post bariatric surgery)
- Changes in plasma level of PYY Hormone in obese participants(Baseline and 3 month post bariatric surgery)
研究者
Mirey Karavetian
Assistant Professor
Zayed University