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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
ACTRN12609000657224
Ethics application status
Not yet submitted
Date submitted
23/07/2009
Date registered
4/08/2009
Date last updated
4/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Skin changes related to insulin therapy in type 1 diabetes
Scientific title
Skin changes related to insulin therapy in type 1 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 237338 0
Condition category
Condition code
Metabolic and Endocrine 239661 239661 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective observational study of skin changes related to insulin therapy.
Patients will be seen at their routine 3 monthly clinic appointment. All patients will be invited to participate and have thier clinical risk factors assessed and invited to have a skin biopsy and intradermal tesing performed. Those with skin changes will have their clinical risk factors assessed, be asked to complete a short questionnaire about the impact that these skin changes have on their diabetes self manageemnt, and invited to have their skin changes photographed, a skin biopsy taken, intradermal skin testing, and patch testing.
This is not an interventional trial.
Intervention code [1] 237001 0
Not applicable
Comparator / control treatment
Patients with and without skin changes will be compared
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238437 0
skin biopsy- Histological changes will be examined and summarised.
Timepoint [1] 238437 0
12 months after enrollment in the study.
Secondary outcome [1] 244938 0
clinical risk factors- from clinical data (history, examination, blood tests) collected at routine clinical appointments prospectively
Timepoint [1] 244938 0
12 months
Secondary outcome [2] 244998 0
intradermal testing- skin reaction to insulin and the diluent insulin is mixed with
Timepoint [2] 244998 0
12 months
Secondary outcome [3] 245000 0
patch testing- skin reaction to the teflon cannula of the insulin pump
Timepoint [3] 245000 0
12 months
Secondary outcome [4] 245001 0
psychological impact of skin changes by questionnaire
Timepoint [4] 245001 0
12 months

Eligibility
Key inclusion criteria
known type 1 or 2 diabetes
understand the research protocol
consent
Minimum age
5 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
moderate-severe eczema or other skin condition,

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237386 0
Hospital
Name [1] 237386 0
Royal North Shore Hospital (RNSH)
Address [1] 237386 0
Pacific Highways
St Leonards
Sydney NSW 2065
Country [1] 237386 0
Australia
Funding source category [2] 237407 0
Hospital
Name [2] 237407 0
Department of Endocrinology Diabetes Trust Fund
Address [2] 237407 0
Dr Greg Fulcher
Department of Endocrinology
RNSH St Leonards NSW 2065
Country [2] 237407 0
Australia
Primary sponsor type
Hospital
Name
RNSH
Address
Pacific Highways
St Leonards
Sydney NSW 2065
Country
Australia
Secondary sponsor category [1] 236886 0
None
Name [1] 236886 0
Address [1] 236886 0
Country [1] 236886 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239518 0
Ethics committee address [1] 239518 0
Ethics committee country [1] 239518 0
Date submitted for ethics approval [1] 239518 0
17/06/2009
Approval date [1] 239518 0
Ethics approval number [1] 239518 0

Summary
Brief summary
Skin changes such as lipohypertrophy and lipoatrophy affect around 20% of patients with Type 1 Diabetes Mellitus during the course of their illness. There has been very liitle previous research in this area. Little is know about the psychological impact of these changes, the pathophysiology of the changes, or the best treatment. The aim of this study is 1) to investigate clinical, immunological and allergic factors that may be associated with these skin changes, 2) examine the histology of the skin (ie look at the structure of the skin under the microscope) and cells involved in lipodystrophic skin
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29954 0
Address 29954 0
Country 29954 0
Phone 29954 0
Fax 29954 0
Email 29954 0
Contact person for public queries
Name 13201 0
Dr Monique Stone
Address 13201 0
Level 5 Douglas Buidling
RNSH
St Loenards NSW 2065
Country 13201 0
Australia
Phone 13201 0
+61 2 9926 6904
Fax 13201 0
Email 13201 0
stonem@med.usyd.edu.au
Contact person for scientific queries
Name 4129 0
Dr Monique Stone
Address 4129 0
Level 5 Douglas Building
RNSH
St Leonards NSW 2065
Country 4129 0
Australia
Phone 4129 0
+61 2 9926 6904
Fax 4129 0
Email 4129 0
stonem@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results