Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001198819
Ethics application status
Approved
Date submitted
7/11/2012
Date registered
14/11/2012
Date last updated
19/02/2021
Date data sharing statement initially provided
3/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Insulin signal peptide, a novel measure of pancreatic insulin synthesis and production
Scientific title
A study to assess insulin signal peptide (INSsp) as a measure of pancreatic beta islet cell function and mass through clinical studies of blood samples from donors including thoose who are healthy, pre-diabetic and with Type 1 and Type 2 diabetes mellitus
Secondary ID [1] 281413 0
none
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus 287660 0
Insulin signal peptide, a novel measure of pancreatic insulin synthesis and production 287789 0
Condition category
Condition code
Metabolic and Endocrine 287998 287998 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
5 groups of participants will be invited to take part in this study:

1. 100 normal, healthy volunteers (50 men, 50 woman) aged between 20-70

2. 70 female patients referred for glucose load testing in the first trimester of pregnancy.

3. 50 patients with polycystic ovary syndrome (PCOS)

4. 50 patients identified from the population as at risk of having Type 2 Diabetes Mellitus (pre-diabetes)

5. 50 patients each with diagnosed Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus

All participants will attend one clinic visit und undergo
1.a general health and known family health history.
2.a physical exam, including height, weight; blood pressure, heart rate, breathing rate, and temperature.
3. A blood sample
Intervention code [1] 285903 0
Not applicable
Comparator / control treatment
Healthy participants will have no know cardiovascular, diabetic of other endocrine condition which could confound insulin levels.
Control group
Active

Outcomes
Primary outcome [1] 288212 0
validate our preliminary observations on INSsp concentrations in humans by assessing its relationship to insulin, glycated haemoglobin, C-peptide, Body Mass Index, age, glucose and lipid status in 50 fasting, healthy humans. This set of data will serve as a template for comparison with four patient groups that are common clinical groups at risk of hyperglycemic and diabetes complications. These are: 1) polycystic ovary syndrome (PCOS) sufferers, 2) mothers tested early in trimester one for glucose loading and pregnancy related diabetic complications, 3) individuals identified as at risk for the development of Type 2 Diabetes Mellitus (DM) and 4) patients diagnosed with Type 1 and Type 2 DM.
Timepoint [1] 288212 0
Baseline and at 1 and 2 years afterwards
Secondary outcome [1] 299611 0
Validate our porcine insulin signal peptide assay and confirm its ability to act as a biomarker of beta cell function in isolated porcine cell cultures, supernatants and plasma.
Timepoint [1] 299611 0
Baseline and at 1 and 2 years afterwards

Eligibility
Key inclusion criteria
5 groups of participants will be invited to take part in this study:

1. 100 normal, healthy volunteers (50 men, 50 woman) aged between 20-70

2. 70 female patients referred for glucose load testing in the first trimester of pregnancy.

3. 50 patients with polycystic ovary syndrome (PCOS)

4. 50 patients identified from the population as at risk of having Type 2 Diabetes Mellitus (pre-diabetes)

5. 50 patients each with diagnosed Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unwilling or unable to give informed consent

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
20/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
155
Final
Recruitment outside Australia
Country [1] 4612 0
New Zealand
State/province [1] 4612 0

Funding & Sponsors
Funding source category [1] 286176 0
Government body
Name [1] 286176 0
Ministry of Business, Innovation & Employment
Country [1] 286176 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Business, Innovation & Employment
Address
Science and Innovation
Wellington Office
PO Box 5762, Wellington 6145
Country
New Zealand
Secondary sponsor category [1] 284988 0
None
Name [1] 284988 0
Address [1] 284988 0
Country [1] 284988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288243 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 288243 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 288243 0
New Zealand
Date submitted for ethics approval [1] 288243 0
01/11/2012
Approval date [1] 288243 0
15/04/2013
Ethics approval number [1] 288243 0
13/STH/13

Summary
Brief summary
The purpose of this study is to quantify Insulin signal peptide ( INSsp) levels and the ratio of insulin to INSsp (and other pertinent biochemical, demographic and metabolic parameters) in blood taken from healthy volunteers and four patient groups commonly assessed for blood insulin/glucose relationships.

We will measure the blood insulin to insulin signal peptide (INSsp) ratio to provide a measure of pancreatic beta cell function and status that cannot be obtained from insulin measurement alone.
5 groups of patients will be studied.
1. 100 normal, healthy volunteers (50 men, 50 woman) aged between 20-70
2. 70 female patients referred for glucose load testing in the first trimester of pregnancy.
3. 50 patients with polycystic ovary syndrome (PCOS)
4. 50 patients identified from the population as at risk of having T2DM (pre-diabetes)
5. 50 patients each with diagnosed T1DM and T2DM

Blood from all five patient groups will be collected. Individual age, gender, height, weight, blood pressure and personal history will be recorded. Routine biochemical analyses will be performed by Canterbury Health Laboratories, Christchurch. A further 30ml fasting blood will be collected to provide for plasma storage banking at the Christchurch Heart Institute laboratory.
All patients will be followed up at one and two years after recruitment to ascertain development of diabetes and/or review metabolic parameters. Follow up visits will include repeat demographic measurements, review of medical notes/records to determine diabetic status as well as blood measurements of fasting glucose, insulin, INSsp, C-peptide and Hba1c.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34850 0
A/Prof Richard Troughton
Address 34850 0
Christchurch Heart Institute Department of Medicine University of Otago, Christchurch PO Box 4345 Christchurch 8140
Country 34850 0
New Zealand
Phone 34850 0
+643 364 1063
Fax 34850 0
+643 364 1115
Email 34850 0
[email protected]
Contact person for public queries
Name 18097 0
Ms Lorraine Skelton
Address 18097 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 18097 0
New Zealand
Phone 18097 0
+643 364 1063
Fax 18097 0
+643 364 0935
Email 18097 0
[email protected]
Contact person for scientific queries
Name 9025 0
A/Prof A/Prof. Chris Pemberton
Address 9025 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 9025 0
New Zealand
Phone 9025 0
+643-364-0887
Fax 9025 0
+643-364-0818
Email 9025 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No additional documents have been identified.