Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000505808
Ethics application status
Not yet submitted
Date submitted
27/04/2012
Date registered
10/05/2012
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Long term follow up on metabolic characteristics and nutritional aspects following gastric bypass surgery compared with a non surgical group.
Scientific title
Obese patients who have undergone gastric bypass surgery as compared to a non-surgical group. A Long term follow up study of metabolic and nutritional outcomes.
Secondary ID [1] 280379 0
Nil
Universal Trial Number (UTN)
U1111-1130-1613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286355 0
Diabetes 286356 0
Nutrition 286357 0
Condition category
Condition code
Metabolic and Endocrine 286595 286595 0 0
Diabetes
Diet and Nutrition 286596 286596 0 0
Obesity
Surgery 286704 286704 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Roux-en-Y gastric bypass surgery for patients with obesity +/- diabetes. This study will observe glycaemic outcomes, weight loss achieved and maintained, lipid profiles, hypertension rates and micronutrient status following at least 5 years since surgery.
Intervention code [1] 284742 0
Not applicable
Comparator / control treatment
A cohort of subjects who were considered for surgery but did not undergo the procedure
Control group
Active

Outcomes
Primary outcome [1] 287015 0
Glycaemic outcomes assessed using fasting glucose and HbA1c (based on current ADA guidelines for glycaemic assessment following bariatric surgery) , number and dose of diabetes medications required so as to be able to document rates of diabetes remission, or improvement, stability, or worsening of diabetes control.
Timepoint [1] 287015 0
Greater than 5 years since surgery. This outcome is assessed in each patient at one timepoint only (specifically, when contact is made with suitable patients during the data collection period) and is not limited to a maximum time frame. The first procedure was performed in approximately 1990 so the effective maximal follow up time will be 22 years.
Primary outcome [2] 287016 0
Weight loss will be assessed using digital scales and calculations of body mass index and excess weight loss. The data collected during the data collection period will be compared with baseline data collected immediately prior to surgery.
Timepoint [2] 287016 0
Greater than 5 years since surgery. This outcome is assessed in each patient at one timepoint only (specifically, when contact is made with suitable patients during the data collection period) and is not limited to a maximum time frame. The first procedure was performed in approximately 1990 so the effective maximal follow up time will be 22 years.
Primary outcome [3] 287017 0
Frequency of nutritional deficiencies assessed by laboratory analysis of micronutrient concentrations in conjunction with a dietary record.
Timepoint [3] 287017 0
Greater than 5 years since surgery. This outcome is assessed in each patient at one timepoint only (specifically, when contact is made with suitable patients during the data collection period) and is not limited to a maximum time frame. The first procedure was performed in approximately 1990 so the effective maximal follow up time will be 22 years.
Secondary outcome [1] 297205 0
Frequency of Hypertension assessed by sphygmanometer measurements during a clincal examination and use of anti-hypertensive medication, compared with similar data that was collected immediately prior to surgery
Timepoint [1] 297205 0
Greater than 5 years since surgery. This outcome is assessed in each patient at one timepoint only (specifically, when contact is made with suitable patients during the data collection period) and is not limited to a maximum time frame. The first procedure was performed in approximately 1990 so the effective maximal follow up time will be 22 years.
Secondary outcome [2] 297206 0
Ferquency of dyslipidaemia assessed by measurement of fasting lipids along with documentation of the use of lipid lowering medication. This data will be compared with similar data that was collected immediately prior to surgery
Timepoint [2] 297206 0
Greater than 5 years since surgery. This outcome is assessed in each patient at one timepoint only (specifically, when contact is made with suitable patients during the data collection period) and is not limited to a maximum time frame. The first procedure was performed in approximately 1990 so the effective maximal follow up time will be 22 years.

Eligibility
Key inclusion criteria
Roux-en-Y gastric bypass surgery performed by a single surgeon between 1990 and 2007 (Surgery group)
Referred to Obesity clinic for consideration of Roux-en-Y gastric bypass surgery between 1990 and 2007 but surgery did not proceed (Non-surgery group)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous alternative bariatric surgery
Roux-en-Y Gastric Bypass (control group)

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 4277 0
New Zealand
State/province [1] 4277 0

Funding & Sponsors
Funding source category [1] 285150 0
University
Name [1] 285150 0
University of Otago
Country [1] 285150 0
New Zealand
Primary sponsor type
Hospital
Name
Endocrine, diabetes and research centre, Wellington Regional Hospital
Address
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 284012 0
Hospital
Name [1] 284012 0
Wakefield Obesity Clinic
Address [1] 284012 0
Wakefield Hospital
Rintoul Street
Newtown
Wellington 6021
Country [1] 284012 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287164 0
New Zealand Multi-regional ethics comittee
Ethics committee address [1] 287164 0
c/- Ministry of Health
Level 2, Reception
1-3 The Terrace
Wellington
6011
Ethics committee country [1] 287164 0
New Zealand
Date submitted for ethics approval [1] 287164 0
08/05/2012
Approval date [1] 287164 0
Ethics approval number [1] 287164 0

Summary
Brief summary
Data is limited on the long term (greater than 5 years) outcomes following gastric bypass surgery. We wish to compare a group of subjects who have had a gastric bypass operation greater than 5 years ago to a group of obese subjects who have not had the same gastric bypass operation. We particularly want to focus on teh effect this procedure has on long term metabolic characteristics such as blood pressure, diabetes and cholesterol as well as some of the possible nutrient imbalances.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34100 0
Address 34100 0
Country 34100 0
Phone 34100 0
Fax 34100 0
Email 34100 0
Contact person for public queries
Name 17347 0
Dr Richard Carroll
Address 17347 0
Endocrine, diabetes and research centre
Wellington Regional hospital
Riddiford Street
Newtown
Wellington 6021
Country 17347 0
New Zealand
Phone 17347 0
+64 4 8062141
Fax 17347 0
+64 4 3855819
Email 17347 0
[email protected]
Contact person for scientific queries
Name 8275 0
Dr Richard Carroll
Address 8275 0
Endocrine, diabetes and research centre
Wellington Regional hospital
Riddiford Street
Newtown
Wellington 6021
Country 8275 0
New Zealand
Phone 8275 0
+64 4 8062141
Fax 8275 0
+64 4 3855819
Email 8275 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
No additional documents have been identified.