Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000049077
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
18/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact of Weight Loss on the Metabolic Syndrome
Scientific title
In obese patients with the metabolic syndrome, we investigate outcomes with weight loss after bariatric surgery using the laparoscopic adjustable gastric band. This is a prospective cohort study monitoring resolution of the risk factors of metabolic syndrome including hypertension, dyslipidaemia and fasting glycaemia and therefore risk profile for cardiovascular disease and Type II diabetes.
Secondary ID [1] 1297 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 252297 0
Metabolic Syndrome 252298 0
Condition category
Condition code
Metabolic and Endocrine 252481 252481 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective cohort study observing the resolution of aspects of the metabolic syndrome with weight loss. Weight loss will be achieved by utilisation of a laparoscopically placed adjustable gastric band (LAGB) by a previously well described technique. Patients will be assessed preoperatively at the Centre for Bariatric Surgery (CBS), a dedicated bariatric surgery centre in Melbourne. They will have baseline blood tests reviewed and anthropometric measurements taken including weight, height, waist, neck and hip circumference. If they satisfy the criteria for the Metabolic syndrome as set out in the Adult treatment Panel III (ATP III) guidelines,they will be invited to take part in the study. Patients will be followed up at CBS by surgeons and physicians. They will be followed monthly for 9 months, and 3 monthly thereafter to a total of 24 months. Their progress will be reviewed, they will have adjustments to the band, and be given advice on achieving their weight loss goals. They will have their anthropometric parameters assessed by the same team of staff utilising the same instruments and methods. They will have blood tests performed at each visit.
Intervention code [1] 241616 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253356 0
Weight loss - Total and percent excess weight loss. Calibrated scales used at the same clinic for baseline and ongoing measurement of weight in kg.
Timepoint [1] 253356 0
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 24 months
Primary outcome [2] 253357 0
Glycaemia/impaired fasting glucose/type II diabetes/ insulin resistance - Assessed by monthly bloods tests - fasting blood glucose,c-peptide,insulin levels, 3 monthly glycated haemoglobin (HbA1c), and calculated homeostasis model assessment of insulin resistance (HOMA IR).
Timepoint [2] 253357 0
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 24 months
Primary outcome [3] 253358 0
Hypertension - utilising a sphygmomanometer -calibrated regularly. Antihypertensive medication use documented and changes in medication noted at each visit.
Timepoint [3] 253358 0
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 24 months
Primary outcome [4] 253359 0
Dyslipidaemia - baseline and ongoing lipid profile from blood analysis - Cholesterol, Triglycerides, High density lipoprotein (HDL)-Cholesterol, Low density lipoprotein (LDL)-Cholesterol, LDLC/HDLC, Chol/HDLC
Timepoint [4] 253359 0
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 24 months
Primary outcome [5] 253360 0
Waist circumference - using World Health Organisation (WHO) guidelines - trained clinic staff measuring at a line above the iliac crest, below the lowest rib - and directly around in a horizontal plane at end expiration.
Timepoint [5] 253360 0
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 18, 21, 24 months
Primary outcome [6] 253361 0
Change in gastrointestinal hormones -Protein YY (PYY), Glucagon like peptide 1 (GLP-1), Grehlin, total pancreatic polypeptide (PP) - blood analysis in collaborator's laboratory in the United Kingdom.
Timepoint [6] 253361 0
Baseline, 12 months, 24 months
Primary outcome [7] 253362 0
Adipose tissue inflammation - macrophage recruitment in subcutaneous and visceral fat depots - Using histology and immunohistochenstry - adipose tissue will be analysed at the Walter and Eliza Hall Institute in Melbourne.
Timepoint [7] 253362 0
baseline
Primary outcome [8] 253363 0
Hepatic steatosis, and non-alcoholic steatohepatitis via core biopsy
Timepoint [8] 253363 0
Baseline
Secondary outcome [1] 262442 0
Quality of Life - SF-36 questionaire
Timepoint [1] 262442 0
baseline 12, 24 months

Eligibility
Key inclusion criteria
Obese patients Body Mass Index > 30
3 or more of Adult Treatment Panel III (ATPIII) criteria
Waist circumference >102 for men > 88cm for women.
Blood pressure >130/85 or being treated for hypertension.
Serum triglycerides >1.7mmol/L.
High Density Lipoprotein (HDL) cholesterol < 1.0 for men, < 1.3 for women.
Serum fasting glucose >5.6mmol/L
Fit For surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unfit for surgery.
Type I diabetes.
Unable to consent to trial.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256097 0
University
Name [1] 256097 0
Monash University
Country [1] 256097 0
Australia
Funding source category [2] 256098 0
Commercial sector/Industry
Name [2] 256098 0
Allergan - unrestricted research grant
Country [2] 256098 0
Australia
Funding source category [3] 256109 0
Other
Name [3] 256109 0
Royal Australasian College of Surgeons - Foundation for Surgery Research Scolarship
Country [3] 256109 0
Australia
Primary sponsor type
University
Name
Monash University - Centre for Obesity Research and Education
Address
CORE, Level 3 Monash Medical School,
Alfred Hospital
Commercial Road,
Prahran VIC 3004
Country
Australia
Secondary sponsor category [1] 251454 0
None
Name [1] 251454 0
Address [1] 251454 0
Country [1] 251454 0
Other collaborator category [1] 977 0
Individual
Name [1] 977 0
Dr John Wentworth
Address [1] 977 0
Clinical Researcher
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville, 3050, VIC
Country [1] 977 0
Australia
Other collaborator category [2] 978 0
Individual
Name [2] 978 0
Dr Carel Le Roux
Address [2] 978 0
Metabolic Physician
Imperial College London,
South Kensington Campus,
London SW7 2AZ
Country [2] 978 0
United Kingdom
Other collaborator category [3] 979 0
Individual
Name [3] 979 0
Dr Ken Sikaris
Address [3] 979 0
Director of Chemical Pathology. Melbourne Pathology, 103 Victoria Parade,Collingwood, Vic, 3066
Country [3] 979 0
Australia
Other collaborator category [4] 981 0
Individual
Name [4] 981 0
A/Prof Michael Bailey
Address [4] 981 0
Department of Epidemiology & Preventive Medicine, Faculty of Medicine, Nursing & Health Sciences, Monash University, 3rd floor of the Burnet Building, Alfred Hospital, Commercial Road, Prahran, VIC 3004
Country [4] 981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258194 0
Monash University Standing Committee on Ethics in Research Involving Humans (SCERH)
Ethics committee address [1] 258194 0
Ethics committee country [1] 258194 0
Australia
Date submitted for ethics approval [1] 258194 0
Approval date [1] 258194 0
13/01/2009
Ethics approval number [1] 258194 0
2009000038
Ethics committee name [2] 258220 0
The Avenue Hospital Human Research Ethics Committee (HREC)
Ethics committee address [2] 258220 0
Ethics committee country [2] 258220 0
Australia
Date submitted for ethics approval [2] 258220 0
Approval date [2] 258220 0
04/05/2009
Ethics approval number [2] 258220 0
099

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30558 0
Address 30558 0
Country 30558 0
Phone 30558 0
Fax 30558 0
Email 30558 0
Contact person for public queries
Name 13805 0
Dr Lisa Doyle
Address 13805 0
Centre for Obesity Research and Education
3rd Floor, Monash Medical School,
The Alfred Hospital,
Prahran, VIC, 3004
Country 13805 0
Australia
Phone 13805 0
61 3 9903 0721
Fax 13805 0
61 3 9903 0171
Email 13805 0
[email protected]
Contact person for scientific queries
Name 4733 0
Dr Lisa Doyle
Address 4733 0
Centre for Obesity Research and Education
3rd Floor, Monash Medical School,
The Alfred Hospital,
Prahran, VIC, 3004
Country 4733 0
Australia
Phone 4733 0
61 3 9903 0721
Fax 4733 0
61 3 9903 0171
Email 4733 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Bariatric Surgery on Liver Function Tests in Patients with Nonalcoholic Fatty Liver Disease.2017https://dx.doi.org/10.1007/s11695-016-2482-8
EmbaseModified thresholds for fibrosis risk scores in nonalcoholic fatty liver disease are necessary in the obese.2017https://dx.doi.org/10.1007/s11695-016-2246-5
EmbaseWeight loss after laparoscopic adjustable gastric band and resolution of the metabolic syndrome and its components.2017https://dx.doi.org/10.1038/ijo.2017.59
EmbaseDetailed Description of Change in Serum Cholesterol Profile with Incremental Weight Loss After Restrictive Bariatric Surgery.2018https://dx.doi.org/10.1007/s11695-017-3015-9
N.B. These documents automatically identified may not have been verified by the study sponsor.