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Trial registered on ANZCTR


Registration number
ACTRN12618001991202
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
12/12/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationship between Metabolic disease, Inflammation, Microbiome & Obesity (MIMO): prospective clinical data collection in obese patients during lifestyle and gastric surgery intervention
Scientific title
Relationship between Metabolic disease, Inflammation, Microbiome & Obesity (MIMO)): prospective clinical data collection in obese patients during lifestyle and gastric surgery intervention
Secondary ID [1] 296664 0
Nil
Universal Trial Number (UTN)
U1111-1224-2811
Trial acronym
MIMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 310502 0
Diabetes 310503 0
Condition category
Condition code
Metabolic and Endocrine 309210 309210 0 0
Diabetes
Metabolic and Endocrine 309211 309211 0 0
Metabolic disorders
Diet and Nutrition 309212 309212 0 0
Obesity
Diet and Nutrition 309213 309213 0 0
Other diet and nutrition disorders
Surgery 309214 309214 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312972 0
Treatment: Surgery
Intervention code [2] 312973 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308181 0
Weight loss, assessed by measuring changes in weight.by a digital scale.
Timepoint [1] 308181 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Primary outcome [2] 308182 0
Diabetes control, assessed by blood tests (glucose and HbA1c) and requirement of diabetes medications determined by an endocrinologist as a composite outcome.
Timepoint [2] 308182 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Primary outcome [3] 308337 0
Body composition, assessed by Dual X-ray Absorptiometry
Timepoint [3] 308337 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [1] 354187 0
Bone health assessment, assessed by Dual X-ray Absorptiometry at spine and hip sites measuring bone mineral density
Timepoint [1] 354187 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [2] 354188 0
Liver health assessment by fibroscan, measuring fatty liver and fibrosis as an composite outcome.
Timepoint [2] 354188 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [3] 354189 0
Changes in microbiome. This is exploratory outcome, assessed by Multitag sequencing.
Timepoint [3] 354189 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [4] 354190 0
Psychosocial assessment, using questionnaires such as SF-36, as a composite outcome.
Timepoint [4] 354190 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [5] 354191 0
Dietary assessment, using questionnaires such as 3 day food recall, 3 factor eating scale, as a composite outcome.
Timepoint [5] 354191 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [6] 354192 0
Physical function assessment, using handgrip test.
Timepoint [6] 354192 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [7] 354757 0
Physical function assessment, using TUGT test.
Timepoint [7] 354757 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [8] 354758 0
Physical function assessment, using isometric muscle strength test, eg quadriceps strength.
Timepoint [8] 354758 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [9] 354879 0
Psychosocial assessment, using questionnaires such as Wisconsin sorting task
Timepoint [9] 354879 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [10] 354880 0
Psychosocial assessment, using questionnaires such as Stroop test.
Timepoint [10] 354880 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.
Secondary outcome [11] 354881 0
Psychosocial assessment, using questionnaires such as Obesity and weight loss QoL, as a composite outcome
Timepoint [11] 354881 0
Before lifestyle or surgical intervention, then 1, 3, 6, 12 months and then yearly after intervention for 4 years.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be transferred from written data sheets to MS Excel, GraphPad Prism, SPSS or other statistical packages to facilitate statistical analysis. Standard descriptive and statistical modelling approaches will be employed to analyse the data in regards to the objectives listed above.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12468 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 12469 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 12470 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 24769 0
2148 - Blacktown
Recruitment postcode(s) [2] 24770 0
2747 - Kingswood
Recruitment postcode(s) [3] 24771 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 301243 0
Self funded/Unfunded
Name [1] 301243 0
Golo Ahlenstiel
Address [1] 301243 0
Western Sydney University, Marcel Cres, Blacktown Hospital, Blacktown NSW 2148
Country [1] 301243 0
Australia
Funding source category [2] 301367 0
Government body
Name [2] 301367 0
Western Sydney Local Health District
Address [2] 301367 0
Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145
Country [2] 301367 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 300876 0
University
Name [1] 300876 0
Western Sydney University
Address [1] 300876 0
Blacktown Clinical School, Marcel Cres, Blacktown Hospital, Blacktown NSW 2148
Country [1] 300876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301981 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301981 0
Westmead Hospital, Hawkesbury Rd, Westmead, NSW 2145
Ethics committee country [1] 301981 0
Australia
Date submitted for ethics approval [1] 301981 0
15/11/2017
Approval date [1] 301981 0
09/10/2018
Ethics approval number [1] 301981 0
HREC/17/WMEAD/552

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88758 0
Prof Golo Ahlenstiel
Address 88758 0
Western Sydney University,
Marcel Cres,
Blacktown Hospital, Blacktown
NSW 2148
Country 88758 0
Australia
Phone 88758 0
+61 2 98516060
Fax 88758 0
Email 88758 0
g.ahlenstiel@westernsydney.edu.au
Contact person for public queries
Name 88759 0
Dr Vita Birzniece
Address 88759 0
Western Sydney University,
Marcel Cres,
Blacktown Hospital, Blacktown
NSW 2148
Country 88759 0
Australia
Phone 88759 0
+61 2 98516059
Fax 88759 0
Email 88759 0
v.birzniece@westernsydney.edu.au
Contact person for scientific queries
Name 88760 0
Dr Vita Birzniece
Address 88760 0
Western Sydney University,
Marcel Cres,
Blacktown Hospital, Blacktown
NSW 2148
Country 88760 0
Australia
Phone 88760 0
+61 2 98516059
Fax 88760 0
Email 88760 0
v.birzniece@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results