Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000462583
Ethics application status
Approved
Date submitted
23/04/2015
Date registered
12/05/2015
Date last updated
12/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Insulin-induced weight gain in type 2 diabetes
Scientific title
Weight gain one year after insulin initiation for type 2 diabetes
Secondary ID [1] 286557 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 294802 0
Weight gain 294916 0
Condition category
Condition code
Metabolic and Endocrine 295079 295079 0 0
Diabetes
Diet and Nutrition 295165 295165 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Patients with type 2 diabetes who are commenced on insulin while attending the Royal Melbourne Hospital Diabetes Clinic. Observation from 6 months before insulin initiation up to 18 months after. Patients included if there was weight data available within this time period, from 1998 to 2014.
Intervention code [1] 291662 0
Not applicable
Comparator / control treatment
Compared with baseline characteristics (no controls)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294843 0
Weight gain. Assessed by clinic scales and then obtained from the Royal Melbourne Hospital Diabetes Database
Timepoint [1] 294843 0
From baseline (183 days before to 60 days after insulin administration), up to 335 to 548 days post insulin initiation (up to data point available within this time frame closest to 1 year mark)
Secondary outcome [1] 314184 0
HbA1c from pathology ordered during routine clinical care. Data from The Royal Melbourne Hospital Diabetes Database.
Timepoint [1] 314184 0
Assessed at baseline (from 183 days before insulin initiation, up to 45 days after) and 1 year (the outcome closest to the one year time point within the rang 305 days to 548 days post insulin initiation)
Secondary outcome [2] 314185 0
Lipid studies from pathology ordered during routine clinical care. Data from The Royal Melbourne Hospital Diabetes Database.
Timepoint [2] 314185 0
Assessed from 365 days before insulin initiation to 720 days after.
Secondary outcome [3] 314186 0
Blood pressure. Assessed in diabetes clinic during routine clinical practice by manual sphygmomanometry, values obtained from The Royal Melbourne Hospital Diabetes Database
Timepoint [3] 314186 0
From baseline (183 days before to 60 days after insulin administration), up to 335 to 548 days post insulin initiation (up to data point available within this time frame closest to 1 year mark)

Eligibility
Key inclusion criteria
Patients with type 2 diabetes who started insulin while attending Royal Melbourne Hospital (RMH) Diabetes clinic, with a baseline weight at insulin initiation defined as up 6 months before to 2 months after and a 1 year weight (at 11 to 18 months)
Minimum age
29 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
type 1 diabetes, gestational diabetes, secondary diabetes, no weight data in specified times, insulin commenced before attending clinic at RMH

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Weight gain tertiles will be compared by non-parametric ANOVA
Baseline correlates of weight gain will be identified by multiple regression analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
2/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3716 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 291120 0
Hospital
Name [1] 291120 0
Royal Melbourne Hospital
Country [1] 291120 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan Street, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 289795 0
None
Name [1] 289795 0
none
Address [1] 289795 0
none
Country [1] 289795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292700 0
Melbourne Health Office for Research
Ethics committee address [1] 292700 0
6 East, Main Building, Royal Melbourne Hospital, 300 Grattan Street Parkville VIC 3050
Ethics committee country [1] 292700 0
Australia
Date submitted for ethics approval [1] 292700 0
Approval date [1] 292700 0
19/08/2014
Ethics approval number [1] 292700 0
QA2014142

Summary
Brief summary
This project aims to determine: 1. the prevalence of weight gain in patients with T2DM who are treated with insulin at RMH; 2. the impact of weight gain on clinical variables such as blood pressure and lipid levels; and 3. to find factors that predict the occurrence of weight gain in people with type-2 diabetes treated with insulin.
Hypothesis:Weight gain prevalence will be greater than 60% in the studied population of type 2 diabetics treated with insulin. This weight gain will be variable depending on baseline characteristics such as starting weight, insulin characteristics and use of oral hypoglycaemics. Patients who gain weight will show a worsening of their cardiovascular risk profile when compared to those who do not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56626 0
Miss Ramina Yadgar-Yalda
Address 56626 0
Royal Melbourne Hospital, 300 Grattan Street Parkville VIC 3050
Country 56626 0
Australia
Phone 56626 0
+61439367496
Fax 56626 0
Email 56626 0
[email protected]
Contact person for public queries
Name 56627 0
Miss Ramina Yadgar-Yalda
Address 56627 0
Royal Melbourne Hospital, 300 Grattan Street Parkville VIC 3050
Country 56627 0
Australia
Phone 56627 0
+61439367496
Fax 56627 0
Email 56627 0
[email protected]
Contact person for scientific queries
Name 56628 0
Miss Ramina Yadgar-Yalda
Address 56628 0
Royal Melbourne Hospital, 300 Grattan Street Parkville VIC 3050
Country 56628 0
Australia
Phone 56628 0
+61439367496
Fax 56628 0
Email 56628 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
EmbaseFactors associated with insulin-induced weight gain in an Australian type 2 diabetes outpatient clinic.2016https://dx.doi.org/10.1111/imj.13122
N.B. These documents automatically identified may not have been verified by the study sponsor.