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Trial registered on ANZCTR


Registration number
ACTRN12613000188730
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
18/02/2013
Date last updated
9/07/2021
Date data sharing statement initially provided
9/07/2021
Date results provided
9/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The association between Neuropeptide Y (NPY) peptide/ Gut Hormones and skeletal health
Scientific title
Patients with obesity undergoing undergoing bariatric surgery or enrolled in an intense medical management plan: comparison of bone mass loss induced by different weight loss modalities.
Secondary ID [1] 281877 0
None
Universal Trial Number (UTN)
U1111-1139-1265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 288262 0
The degree of bone loss in obese subjects following massive weight loss 288263 0
An impact of bariatric surgery and gut hormones on bone mass 288264 0
Condition category
Condition code
Musculoskeletal 288615 288615 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 288616 288616 0 0
Other metabolic disorders
Diet and Nutrition 288705 288705 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this project is to define the role of neuropeptides and gut hormones in the regulation of adipose and bone metabolism in patients undergoing massive weight loss.

Each patient will attend 6 study visits: at baseline 0, 1, 3, 6, 12, 24 and 36 months with the extended follow up for the surgical groups up to 3 years post interventions.

The following tests will be carried out during the study:

Height, weight and waist measurements: these will be measured at each study visit.

Blood Collection at each visit: for biochemistry including urea, creatinine, electrolytes (UEC), full blood count (FBC), liver function tests (LFT), HbA1c in patients with DM, total cholesterol, HDL, LDL and triglycerides, fasting BSL and insulin, mineral and vitamin levels relevant to this study as well as gut hormones: peptide YY, measuring both full length (PYY 1-36) and the fragment (PYY 3-36), ghrelin, glucagon like peptide (GLP-1), leptin as well as adiponectin.For the surgical subjects, screening prior to the study will be done to exclude abnormal hormonal status such as hypercortisolaemia, hypogonadism and thyroid dysfunction.

Meal studies at visits: 0, 6 months (optional), 12 and 36 months to assess postprandial response of gut hormones

Bone and calcium markers: at baseline, 3, 6, 12 months and 24 months calcium balance will be assessed by 24-hour urine calcium collections. Calcium, phosphate, albumin, intact parathyroid hormone and 25-hydroxyvitamin D as well as markers of bone formation (serum osteocalcin) and bone resorption (urinary N telopeptide (NTx) will be measured at these time points.

Bone mineral densitometry scan (BMD DXA): at visits: 0, 12 months, 24 months and 36 months to assess BMD and body composition
Quantitative Computed Tomography (QCT): at visits: 0, 12 months and 2 years to assess BMD and abdominal fat mass

3 day food diary analysis with nutrient assessments at each visit.

Questionnaires including:
The Satiety Assessment Questionnaire
The Physical Activity Questionnaire (3-day recall, once a month)

Calcium and vitamin D supplements will be recommended to all subjects to aim for total calcium intake from diet and supplements> 1000mg a day and 25(OH) vitamin D level>75nM.
Intervention code [1] 286441 0
Not applicable
Comparator / control treatment
Obese subjects undergoing intense diet and lifestyle changes represent an active control group for this study. For non-surgery patients overall dietary intervention will be based on individualized calorie goal (1000-1500 calories/day) determined from the patient’s baseline body weight. The fat intake will be restricted to 20% calories. This ideally should be achieved with optifast meal replacements.
Control group
Active

Outcomes
Primary outcome [1] 288771 0
To determine the degree of bone loss in obese subjects following massive weight loss.

All patients will undergo antropometric assessments at each visit. Their BMD will be measured by BMD DXA scan at the whole body, lumbar spine, proximal femur and one-third distal radius as well as by QCT scan at lumbar spine at 0, 12 and 24 months post intervention
Timepoint [1] 288771 0
0, 12 and 24 months post intervention
Primary outcome [2] 288772 0
To determine changes in levels of gut hormones, neuropeptides, leptin, adiponectin following weight loss through different modalities of bariatric surgery and intense medical management.

All patients will undergo blood collection for measurement of their fasting gut hormones, neuropeptides, leptin, adiponectin at each visit as well as meal studies at 0 and 12months to assess postprandial gut hormones response.
Timepoint [2] 288772 0
0 and 12 months post intervention
Primary outcome [3] 288773 0
To determine changes in satiety and appetite in patients who undergo massive weight loss through obesity surgery and medical management

Patients' satiety and appetite will be measured using the Satiety and Appetite Assessments Questionnaire at each visit
Timepoint [3] 288773 0
12 and 24 months post intervention
Secondary outcome [1] 300940 0
To determine differences in weight loss achieved through different types of bariatric surgery and intense medical management.

All patients will undergo antropometric assessments at each visit as well as will have changes in their body composition assessed through DXA and QCT at 0, 12 and 24months
Timepoint [1] 300940 0
0, 12 and 24 months post intervention
Secondary outcome [2] 300941 0
To determine improvement in metabolic parameters achieved through different types of bariatric surgery and intense medical management at study strategic points.

All patients will undergo measurements of fasting BSL, lipids, HbA1c as appropriate for routine follow up of these subjects at all time points.
Timepoint [2] 300941 0
0, 1, 3, 6, 12 and 24months post intervention

Eligibility
Key inclusion criteria
1) BMI> 40 or BMI> 35 with medical complication from obesity
2) Presence of obesity for the last 5 years, which has persisted despite multiple attempts with other weight loss measures
3) Patient who is either undergoing bariatric surgery or who is enrolled into the intense medical management plan with the aim to lose significant amount of weight.
4) Willingness and ability to comply with the protocol of the study
5) Willingness to provide written informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Pregnancy or patient planning pregnancy in next 2 years of the study
2) Women, who are within 5 years after the onset of menopause
3) Intake of medications known to affect bone mineral density (BMD)
4) Active alcohol or drug dependency
5) Active psychosocial or psychiatric problem that would make adherence to the protocol difficult

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
1/08/2012
Actual
1/08/2012
Date of last data collection
Anticipated
Actual
15/11/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 533 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 534 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 6274 0
2217 - Kogarah
Recruitment postcode(s) [2] 6275 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 286687 0
Government body
Name [1] 286687 0
National Health and Medical Research Council
Country [1] 286687 0
Australia
Funding source category [2] 286688 0
Charities/Societies/Foundations
Name [2] 286688 0
The Perpetual Foundation
Country [2] 286688 0
Australia
Funding source category [3] 286689 0
Hospital
Name [3] 286689 0
Nuclear Medicine Department, St Vincent's Hospital
Country [3] 286689 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jacqueline Ruth Center
Address
Garvan Institute of Medical Research, 384 Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285458 0
Individual
Name [1] 285458 0
Dr Malgorzata Brzozowska
Address [1] 285458 0
Garvan Institute of Medical Research, 384 Victoria Street, Darlinghurst NSW 2010
Country [1] 285458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288752 0
St Vincent's Hospital HREC
Ethics committee address [1] 288752 0
Ethics committee country [1] 288752 0
Australia
Date submitted for ethics approval [1] 288752 0
20/05/2009
Approval date [1] 288752 0
21/07/2009
Ethics approval number [1] 288752 0
HREC/09/SVH/64

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

Contacts
Principal investigator
Name 37538 0
Dr Malgorzata Monika Brzozowska
Address 37538 0
Garvan Institute of Medical Research, 384 Victoria street, Darlinghurst, NSW 2010
Country 37538 0
Australia
Phone 37538 0
(+61) 2 9295 8240
Fax 37538 0
Email 37538 0
m.brzozowska@garvan.org.au
Contact person for public queries
Name 37539 0
Jacqueline Ruth Center
Address 37539 0
Garvan Institute of Medical Research, 384 Victoria street, Darlinghurst, NSW 2010
Country 37539 0
Australia
Phone 37539 0
(+61) 2 9295 8271
Fax 37539 0
Email 37539 0
j.center@garvan.org.au
Contact person for scientific queries
Name 37540 0
Jacqueline Ruth Center
Address 37540 0
Garvan Institute of Medical Research, 384 Victoria street, Darlinghurst, NSW 2010
Country 37540 0
Australia
Phone 37540 0
(+61) 2 9295 8271
Fax 37540 0
Email 37540 0
j.center@garvan.org.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 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
EmbaseRoux-en-Y gastric bypass and gastric sleeve surgery result in long term bone loss.2021https://dx.doi.org/10.1038/s41366-020-00660-x
EmbaseEffects of bariatric surgery and dietary intervention on insulin resistance and appetite hormones over a 3 year period.2023https://dx.doi.org/10.1038/s41598-023-33317-6
N.B. These documents automatically identified may not have been verified by the study sponsor.