Insulin signal peptide, a novel measure of pancreatic insulin synthesis and productio

Not Applicable

Recruiting

• Conditions: diabetes mellitus; Insulin signal peptide, a novel measure of pancreatic insulin synthesis and production; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12612001198819
• Lead Sponsor: Ministry of Business, Innovation & Employment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

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

Exclusion Criteria

unwilling or unable to give informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ Baseline and at 1 and 2 years afterwards]

Secondary Outcome Measures

Name	Time	Method
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.[ Baseline and at 1 and 2 years afterwards]