Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000739617
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
11/11/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Microvascular Complications in Patients with Type 1 Diabetes
Scientific title
Microvascular complications in patients with Type 1 Diabetes. To determine the relationship between abnormalities of autonomic function and markers of microvascular disease and cardiovascular risk in patients with Type 1 Diabetes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 891 0
Condition category
Condition code
Metabolic and Endocrine 959 959 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Type 1 diabetes is associated with the development of microvascular complications including nephropathy, retinopathy, peripheral and autonomic neuropathies. Diabetic autonomic neuropathy is a serious yet under-recognised complication. It is thought that the presence of autonomic neuropathy heralds more widespread implications both in terms of cardiovascular risk and its close relationship to other microvascular complications.
This study hopes to determine the relationship between autonomic neuropathy, markers of microvascular disease and cardiovascular risk.
This cross-sectional analysis of the study population at a single site will consist of an initial visit when the patient will present to the clinic in a fasting state. At this visit the patient will have the following procedures:
1. Two measures of autonomic function (pupilometry and R-R variability).
2. Pulse wave analysis
3. HbA1c, EUC, B-type natriuretic peptide (BNP) and lipid levels
4. Retinal photography
5. Neurothesiometry
6. Electronic Blood pressure
7. Fitting of a 24 hour ambulatory blood pressure monitor
8. A timed overnight urine measurement of Albumin Excretion Rate
9. A 24 hour urine collection to measure Creatinine Clearance
10. Ankle Brachial Index measurement
The patient will be asked to return in 12 months time and have a repeat of all the procedures.
Intervention code [1] 668 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1264 0
1. To determine the prevalence of autonomic neuropathy by two different techniques in patients with Type 1 Diabetes of short and longer duration.
Timepoint [1] 1264 0
Primary outcome [2] 1265 0
2. To determine the characteristics of patients with and without autonomic neuropathy including the prevalence of other microvascular complications of diabetes (retinopathy/nephropathy/neuropathy) in the groups.
Timepoint [2] 1265 0
Primary outcome [3] 1266 0
3. To determine the prevalence of non-dipping of blood pressure in patients with and without autonomic neuropathy (as determined by pupillometry or R-R variability).
Timepoint [3] 1266 0
Primary outcome [4] 1267 0
4. To determine the effect of non-dipping on the vasculature according to pulse-wave analysis, and on renal function as assessed by creatinine clearance and the presence of microalbuminuria.
Timepoint [4] 1267 0
Primary outcome [5] 1268 0
5. To determine longitudinal development (at least 12 months) of markers of microvascular disease in patients with baseline autonomic neuropathy but no baseline microvascular disease.
Timepoint [5] 1268 0
Primary outcome [6] 1269 0
6. To determine the B-type natriuretic peptide (BNP) level which is a polypeptide produced by the cardiac ventricles and has been found to be sensitive and a specific marker of left ventricular dysfunction.
Timepoint [6] 1269 0
Secondary outcome [1] 2299 0
1. HbA1c
Timepoint [1] 2299 0
Secondary outcome [2] 2300 0
2. Lipids
Timepoint [2] 2300 0
Secondary outcome [3] 2301 0
3. Fasting glucose
Timepoint [3] 2301 0

Eligibility
Key inclusion criteria
1. Patients who have been informed of the study procedure and have given written informed consent.2. Unequivocal diagnosis of Type 1 diabetes mellitus.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are unwilling or unable to attend the clinic on two consecutive days.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1057 0
Hospital
Name [1] 1057 0
Sydney Diabetes Clinical Research Unit, Royal North Shore Hospital
Country [1] 1057 0
Australia
Primary sponsor type
Hospital
Name
Sydney Diabetes Clinical Research Unit, Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 918 0
None
Name [1] 918 0
N/A
Address [1] 918 0
Country [1] 918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2355 0
Sydney Diabetes Clinical Research Unit
Ethics committee address [1] 2355 0
Ethics committee country [1] 2355 0
Australia
Date submitted for ethics approval [1] 2355 0
Approval date [1] 2355 0
Ethics approval number [1] 2355 0
Ethics committee name [2] 2356 0
Royal North Shore Hospital
Ethics committee address [2] 2356 0
Ethics committee country [2] 2356 0
Australia
Date submitted for ethics approval [2] 2356 0
Approval date [2] 2356 0
Ethics approval number [2] 2356 0

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

Contacts
Principal investigator
Name 35578 0
Address 35578 0
Country 35578 0
Phone 35578 0
Fax 35578 0
Email 35578 0
Contact person for public queries
Name 9857 0
Ms Caitlin Scott
Address 9857 0
Sydney Diabetes Clinical Research Unit
Royal North Shore Hospital
Level 3
Main Block
St Leonards NSW 2065
Country 9857 0
Australia
Phone 9857 0
+61 2 99266879
Fax 9857 0
+61 2 94395181
Email 9857 0
cscott@nsccahs.health.nsw.gov.au
Contact person for scientific queries
Name 785 0
Dr Anne McCormack
Address 785 0
Endocrinology
Royal North Shore Hospital
Level 3
Main Block
St Leonards NSW 2065
Country 785 0
Australia
Phone 785 0
+61 2 99268388
Fax 785 0
+61 2 94395181
Email 785 0
mccormackann@optushome.com.au

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.