None listed
Conditions
Brief summary
The study aims to examine the relationship between obesity, metabolism, inflammation and the microbiome, and how these are modulated by therapeutic intervention. This will allow identification of outcome predictors pre-intervention. Hypothesis is that obesity, i.e. pathogenesis, clinical phenotype and response to therapy, are driven by dysregulation of metabolic state, gut microbiome and chronic inflammation as well as psychosocial factors.This study will provide novel data in a rigorous, well-characterized large cohort of patients that will enhance our understanding of the function and complex dynamic interplay between the gut microbiome, metabolics, genetics and inflammation.
Interventions
Lifestyle and surgical intervention (bariatric surgery).
This will be achieved by a dietician, endocrinologist and gastric surgeon, aiming to reduce body weight to healthy BMI level (below 25 kg/m2).
Lifestyle modifications will be tailored to each patient's need and will be continuous throughout the program. Lifestyle modifications will be delivered by a dietician and endocrinologist at group sessions of patient education by lectures and group discussions for 2 hrs at the start of enrolment i
Lifestyle and surgical intervention (bariatric surgery). This will be achieved by a dietician, endocrinologist and gastric surgeon, aiming to reduce body weight to healthy BMI level (below 25 kg/m2). Lifestyle modifications will be tailored to each patient's need and will be continuous throughout the program. Lifestyle modifications will be delivered by a dietician and endocrinologist at group sessions of patient education by lectures and group discussions for 2 hrs at the start of enrolment into the program at participating hospitals. It will consist of diet review and advice of healthy eating and exercise, as per dietician and endocrinologist specialist recommendations. The program and expected benefits are discussed and an agreed upon management is reached in consultation with the patient, who is the main driver and focus of the intervention. Total duration of lifestyle program is 12 weeks with weekly or fortnightly review of progress in group sessions, each of 2 hours. Adherence to program will be monitored by periodic measurements of weight, waist circumference, blood pressure and blood tests to document improvement in target obesity-related complications (e.g., diabetes). Bariatric surgery will be performed once, if required as determined by clinicians. Bariatric surgery will be done if patient’s body-mass index is more than 40 kg/m2 or with BMI greater than 35 kg/m2 and 1 or more significant comorbid conditions (e.g. diabetes), when lifestyle modification method of weight loss have failed. Overall, the patient must be deemed eligible by the multi-disciplinary team that their obesity complication or illness will improve with significant weight loss. Bariatric surgery: 1) Laparoscopic sleeve gastrectomy: is a weight loss surgery in which the stomach is reduced to 15-25% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. The result is a sleeve or tube like structure. The procedure permanently reduces the size of the stomach, although there could be some dilatation of the stomach later on in life. The procedure is generally performed laparoscopically and is irreversible. 2) Roux-en-Y Gastric Bypass: A surgical procedure in which the stomach is divided into a small upper pouch and a much larger lower "remnant" pouch and then the small intestine is rearranged to connect to both. This leads to a marked reduction in the functional volume of the stomach, accompanied by an altered physiological and physical response to food. 3) Omega Loop Gastric Bypass: A surgical procedure that is a variant of the Roux-en- gastric bypass in that instead of two connections being made (anastomoses), there is only one. Part of the stomach is joined to the small bowel, 'bypassing the stomach', causing both restriction and malabsorption and promoting weight loss. Most patients will undergo sleeve gastrectomy, however the choice of surgery will be entirely up to surgeon’s discretion. Bariatric surgery will be done regardless of patient’s enrolment in this study. Bariatric surgery takes usually 1-2 hrs to complete. Effectiveness of intervention will be monitored by an endocrinologist. This is done at Blacktown, Nepean and Westmead Hospitals, NSW.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study; • Age greater than 18; • Sex: male, female; • Body mass index greater than 35 kg/m2 PLUS Type 2 Diabetes OR 2 or more obesity-related comorbidities
Exclusion criteria
• Age less than 18 years; • Pregnant or lactating women; • People in existing dependent or unequal relationships with any member of the research team; • People who may be involved in illegal activity; • People highly dependent on medical care; • Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study; • Inability to give written informed consent.
Outcome results
None listed