Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000525987
Ethics application status
Approved
Date submitted
12/02/2009
Date registered
23/05/2011
Date last updated
23/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of bariatric surgery on the adipose hormone adiponectin in obese women.
Scientific title
An observational study of bariatric surgery on adiponectin expression, circulation and receptor number in obese patients.
Secondary ID [1] 251889 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 4323 0
Condition category
Condition code
Diet and Nutrition 4558 4558 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of a bariatric weight loss program investigating the biology of the adipose hormone adiponectin. The intervention will be standard care at a public New Zealand teaching hospital, which will comprise a very low energy diet (VLED) followed by bariatric surgery. Participants will follow the VLED, in the form of Optifast meal replacement, for 4-6 weeks prior to surgery, and then will undergo Roux en Y gastric bypass or sleeve gastrectomy. During surgery tissue biopsy samples will be collected from the abdomen and thigh (adipose, muscle) in addition to the liver . At 6 month follow-up repeat subcutaneous biopsies will be collected from the abdomen and thigh. Blood samples will be collected at pre-VLED, surgery and follow-up, and body composition analyses will be performed at these time points to assess body fat distribution.

Optifast is a mixture of shakes, soups and bars. Usually taken 3 times a day, if this is poorly tolerated or if a longer period is required then only 2 times a day, with a third meal of steamed veges.

Surgery methods
Roux en Y: laparoscopic, 30ml pouch, hand sewn gastrojejeunostomy, 100cm roux limb, hand sewn small bowel anastomosis, 3-4 hours

Sleeve: laparoscopic, narrow gastric sleeve over 32-36 french bougie, 2-3 hours

Body composition measurements:
1. Total body protein (Neutron Activation Analysis)
2. Total body fat (Dual-Energy X-Ray Absorptiometry (DEXA)
3. Total body potassium (TBK)
4. Total body water (Tracer Dilution)
5. Total body water (Bioelectrical Impedance)
6. Skinfolds
7. Grip strength
This is all monitored by health care professionals.
Intervention code [1] 4053 0
Not applicable
Comparator / control treatment
No Treatment. Not applicable – Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5438 0
Adiponectin Gene Expression.
Briefly, the methods involve the routine use of real-time polymerase chain reaction (RT-PCR) for the genetic analyses and enzyme-linked immunosorbent assays (ELISA) for the tissue and plasma adiponectin protein work. Many of the following methods are derived from Dr Aimin Xu et al, Department of Medicine, University of Hong Kong, L8-43, 21 Sassoon Road, Hong Kong, China.
Total ribonucleic acid (RNA) isolation and complementary deoxyribonucleic acid (cDNA) preparation Adiponectin and Receptors
Specimens of all tissue (4 samples of subcutaneous and deep upper body adipose, visceral and thigh, 2 of abdominal wall and thigh muscle and liver) at .3-2 g size will be collected in RNA-Later Applied Biosystems (ABI) (Foster City, CA, USA) and stored at -80C. The tissue will be cut into pieces, and separated, RNALater removed and appropriate washing for batch analysis. Total RNA for the adiponectin gene will be extracted from adipocytes using Trizol reagents and transcribed into cDNA with a Superscript first-strand cDNA synthesis system. The relative gene abundance will be quantified by real-time polymerase chain reaction (PCR) using the assay-on-demand TaqMan primers and probes or ABI Prism (Genetic analyzer) by using PCR Master Mix Reagent, both from Applied Biosystems (Foster City, CA) with the pre-made assay kits. The reactions will be performed in an ABI 7000 sequence detection system. Relative quantification of adiponectin receptors, AdipoR1 and AdipoR2 mRNAs for gene expression will be performed by real-time PCR using a similar system to the above. A reference gene such as hypoxanthine-phosphoribosyl-transferase, or cyclophilin mRNA will be used as it is has been the reference for subcutaneous and visceral adipose, and liver in studies. As with many labs undertaking new work, we have Ethics approval to take some extra visceral adipose tissue to work out our own lab reference genes, and construct and standardize adiponectin and AdipoR1 and AdipoR2 gene reference curves from this reference pool. We also have permission to add to and use our cDNA library of adiponectin and receptor data
Timepoint [1] 5438 0
At surgery and 6 months post-surgery
Primary outcome [2] 5439 0
Adiponectin Protein Expression.
Briefly, the methods involve the routine use of real-time polymerase chain reaction (RT-PCR) for the genetic analyses and enzyme-linked immunosorbent assays (ELISA) for the tissue and plasma adiponectin protein work. Many of the following methods are derived from Dr Aimin Xu et al, Department of Medicine, University of Hong Kong, L8-43, 21 Sassoon Road, Hong Kong, China.
Total ribonucleic acid (RNA) isolation and complementary deoxyribonucleic acid (cDNA) preparation Adiponectin and Receptors
Specimens of all tissue (4 samples of subcutaneous and deep upper body adipose, visceral and thigh, 2 of abdominal wall and thigh muscle and liver) at .3-2 g size will be collected in RNA-Later Applied Biosystems (Foster City, CA, USA) and stored at -80C. The tissue will be cut into pieces, and separated, RNALater removed and appropriate washing for batch analysis. Total RNA for the adiponectin gene will be extracted from adipocytes using Trizol reagents and transcribed into cDNA with a Superscript first-strand cDNA synthesis system. The relative gene abundance will be quantified by real-time PCR using the assay-on-demand TaqMan primers and probes or ABI Prism by using PCR Master Mix Reagent, both from Applied Biosystems (ABI) (Foster City, CA) with the pre-made assay kits. The reactions will be performed in an ABI 7000 sequence detection system. Relative quantification of adiponectin receptors, AdipoR1 and AdipoR2 mRNAs for gene expression will be performed by real-time PCR using a similar system to the above. A reference gene such as hypoxanthine-phosphoribosyl-transferase, or cyclophilin mRNA will be used as it is has been the reference for subcutaneous and visceral adipose, and liver in studies. As with many labs undertaking new work, we have Ethics approval to take some extra visceral adipose tissue to work out our own lab reference genes, and construct and standardize adiponectin and AdipoR1 and AdipoR2 gene reference curves from this reference pool. We also have permission to add to and use our cDNA library of adiponectin and receptor data.
Timepoint [2] 5439 0
At surgery and 6 months post-surgery
Secondary outcome [1] 9136 0
Circulating Adiponectin and Oligomers.
Briefly, the methods involve the routine use of real-time polymerase chain reaction (RT-PCR) for the genetic analyses and enzyme-linked immunosorbent assays (ELISA) for the tissue and plasma adiponectin protein work. Many of the following methods are derived from from Dr Aimin Xu et al, Department of Medicine, University of Hong Kong, L8-43, 21 Sassoon Road, Hong Kong, China.
Total RNA isolation and cDNA preparation Adiponectin and Receptors
Specimens of all tissue (4 samples of subcutaneous and deep upper body adipose, visceral and thigh, 2 of abdominal wall and thigh muscle and liver) at .3-2 g size will be collected in RNA-Later Applied Biosystems (Foster City, CA, USA) and stored at -80C. The tissue will be cut into pieces, and separated, RNALater removed and appropriate washing for batch analysis. Total RNA for the adiponectin gene will be extracted from adipocytes using Trizol reagents and transcribed into cDNA with a Superscript first-strand cDNA synthesis system. The relative gene abundance will be quantified by real-time PCR using the assay-on-demand TaqMan primers and probes or ABI Prism by using PCR Master Mix Reagent, both from Applied Biosystems (Foster City, CA) with the pre-made assay kits. The reactions will be performed in an ABI 7000 sequence detection system. Relative quantification of adiponectin receptors, AdipoR1 and AdipoR2 mRNAs for gene expression will be performed by real-time PCR using a similar system to the above. A reference gene such as hypoxanthine-phosphoribosyl-transferase, or cyclophilin mRNA will be used as it is has been the reference for subcutaneous and visceral adipose, and liver in studies. As with many labs undertaking new work, we have Ethics approval to take some extra visceral adipose tissue to work out our own lab reference genes, and construct and standardize adiponectin and AdipoR1 and AdipoR2 gene reference curves from this reference pool. We also have permission to add to and use our cDNA library of adiponectin and receptor data.
iTRAQ is a method were peptides from 8 different samples can be labeled with isobaric tags (each tag has a slightly different mass).

They are run through an Liquid chromatography-mass spectrometry (LC-MS/MS) to identify what proteins the peptides came from (Protine ID)

The tags give you a reference to what sample they came from and a relative concentration of that protein in relation among samples.
Timepoint [1] 9136 0
At surgery and 6 months post-surgery
Secondary outcome [2] 9137 0
Change in metabolic syndrome and adipocytokines.
Blood pressure mmHg, waist circumference, Body Mass Index kg/m2.
Metabolic markers:
Glucose, Uric acid, Thyroid hormones, Lipid profile (Lipids) Total Cholesterol(TC), High Density Lipoprotein -Cholesterol(HDL-C), Low Density Lipoprotein-Cholesterol(LDL-C), Triacylglyceride(TAG)
Timepoint [2] 9137 0
At surgery and 6 months post-surgery
Secondary outcome [3] 9138 0
Change in body composition.
1Total body protein (Neutron Activation Analysis):
2Total body fat (Dual-Energy X-Ray Absorptiometry (DEXA):
3 Total body potassium (TBK): 4Total body water (Tracer Dilution): 5Total body water (Bioelectrical Impedance)
Timepoint [3] 9138 0
Pre and post-VLED, pre-surgery and 6 months post-surgery

Eligibility
Key inclusion criteria
Phase 1 A Lean: BMI 18.5-25 kg/m2, weight stable and healthy.
Accepted into the Auckland District Health Board Auckland City Hospital General Laparoscopic Upper GI Surgery Clinic. Accepts reversion to open surgery if necessary.
Signed informed consent given.

Phase 1 B Obese: BMI >40 or >35 kg/m2 with co-morbidities and weight stable.
Accepted into the Auckland District Health Board Auckland City Hospital General Laparoscopic Upper GI Surgery Clinic. Accepts reversion to open surgery if necessary.
Signed informed consent given.

Phase 2: Body Mass Index (BMI) >40 kg/m2 or >35 kg/m2 plus co-morbidities of diabetes, polycystic ovary syndrome, fatty liver disease and severe dyslipidaemia.
Accepted for Bariatric Surgery at Auckland City Hospital
Signed informed consent given
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of inflammatory or malignant disease.
Previous obesity surgery – bariatric, liposuction, lipectomy or liposculpture
Pregnant or breastfeeding
Participation in another clinical trial
No weight loss medication of weight programme attendance.
No extreme food restriction and/or excessive physical activity and alters body composition in a short space of time.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 1569 0
New Zealand
State/province [1] 1569 0
Auckland
Country [2] 1570 0
New Zealand
State/province [2] 1570 0

Funding & Sponsors
Funding source category [1] 4496 0
Government body
Name [1] 4496 0
Health Research Council of New Zealand
Country [1] 4496 0
New Zealand
Primary sponsor type
University
Name
The Univeristy of Auckland
Address
The University of Auckland,
Private Bag 92019,Auckland Mail Centre, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 4059 0
None
Name [1] 4059 0
Address [1] 4059 0
Country [1] 4059 0
Other collaborator category [1] 565 0
Individual
Name [1] 565 0
Professor Garth Cooper
Address [1] 565 0
School of Biological Sciences,
The University of Auckland,
Private Bag 92019,Auckland Mail Centre, Auckland 1142
Country [1] 565 0
New Zealand
Other collaborator category [2] 566 0
Individual
Name [2] 566 0
Dr Linsday Plank
Address [2] 566 0
Department of Surgery, Faculty of Medical and Health Sciences, The University of Auckland,
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country [2] 566 0
New Zealand
Other collaborator category [3] 567 0
Individual
Name [3] 567 0
Mr Grant Beban
Address [3] 567 0
Department of Surgery, Auckland City Hospital, Park Rd, Grafton, Private Bag 92024, Auckland Mail Centre,
Auckland 1142
Country [3] 567 0
New Zealand
Other collaborator category [4] 251770 0
University
Name [4] 251770 0
Liggins Institute- Dr Allan Sheppard
Address [4] 251770 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country [4] 251770 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6556 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6556 0
Ethics committee country [1] 6556 0
New Zealand
Date submitted for ethics approval [1] 6556 0
Approval date [1] 6556 0
22/12/2008
Ethics approval number [1] 6556 0
NTX08/10/103

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

Contacts
Principal investigator
Name 29282 0
Address 29282 0
Country 29282 0
Phone 29282 0
Fax 29282 0
Email 29282 0
Contact person for public queries
Name 12529 0
Dr Anne-Thea McGill
Address 12529 0
Human Nutrition Unit
The University of Auckland
18 Carrick Pl, Mt Eden,
Auckland 1024
Country 12529 0
New Zealand
Phone 12529 0
+64 9 6305160
Fax 12529 0
+64 9 6305764
Email 12529 0
[email protected]
Contact person for scientific queries
Name 3457 0
Dr Sally Poppitt
Address 3457 0
Human Nutrition Unit
The University of Auckland
18 Carrick Pl, Mt Eden,
Auckland 1024
Country 3457 0
New Zealand
Phone 3457 0
+64 9 6305160
Fax 3457 0
+64 9 6305764
Email 3457 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
EmbaseDissecting the relationship between plasma and tissue metabolome in a cohort of women with obesity: Analysis of subcutaneous and visceral adipose, muscle, and liver.2022https://dx.doi.org/10.1096/fj.202101812R
N.B. These documents automatically identified may not have been verified by the study sponsor.