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Trial registered on ANZCTR


Registration number
ACTRN12616001542482
Ethics application status
Approved
Date submitted
2/10/2016
Date registered
8/11/2016
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Are high doses of insulin correlated with markers of metabolic stress in patients with type 2 diabetes?
Scientific title
Is there any correlation between metabolic stress markers and exogenous hyperinsulinization in type 2 diabetes?
Secondary ID [1] 290251 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 300465 0
Condition category
Condition code
Metabolic and Endocrine 300321 300321 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This cross-sectional study will examine the association between exogenous insulin dose and inflammation, oxidative stress and endothelin-1 in patients with insulin-treated type 2 diabetes. Measurement of markers of metabolic stress will be done as a single assessment at enrollment into the study. All biomarkers will be compared between patients into the first and third tertile of insulin doses. Mean levels of insulin dose/kg of body weight will be reported for each tertile.
After completion of enrollment, participants will be divided into 3 equal groups based on ordered distribution of their insulin dose/kg of body weight (1st tertile, 2nd tertile and 3rd tertile). Tertile is defined as any of the two points that divide an ordered distribution into three parts, each containing a third of the population.
Intervention code [1] 296039 0
Not applicable
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299788 0
hsCRP difference between 1st and 3rd tertile of insulin dose; hsCRP will be measured from plasma blood samples
Timepoint [1] 299788 0
single measure at enrollment
Secondary outcome [1] 328116 0
comparison of pentraxin 3 between 1st and 3rd tertile of insulin dose; pentraxin will be measured from blood samples
Timepoint [1] 328116 0
single measure at enrollment
Secondary outcome [2] 328117 0
comparison of nitrotyrosine between 1st and 3rd tertile of insulin dose; nitrotyrosine will be measured from blood samples
Timepoint [2] 328117 0
single measure at enrolment
Secondary outcome [3] 328118 0
comparison of endothelin-1 between 1st and 3rd tertile of insulin dose; endothelin will be measured from blood samples
Timepoint [3] 328118 0
single measure at enrollment

Eligibility
Key inclusion criteria
1. adult (>=18 years) patients with type 2 diabetes, treated with insulin for at least 6 months;
2. stable insulin dose (+/- 10%) in the last 3 months;
3. patients who signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
type 1 and other specific types of diabetes including gestational diabetes; diabetic ketoacidosis and hyperglycemic-hyperosmolar state; acute illnesses able to influence current insulin doses; acute infections; ALAT and/or ALAT>3 ori upper normal limit, eGFR<30 ml/min/1,73 m2); antiinflammatory drugs, except aspirin<300 mg/day within the previous 3 months; pregnancy and lactation


Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Based on previous studies reporting hsCRP values in insulin treated type 2 diabetes,, eighty patients should be enrolled to have a 97.1% statistical power to detect a 0.5 mg/dl difference between groups with an alpha value of 5% for a 95% CI.
Patients will be divided in 3 equal groups based on tertiles of insulin dose/kg of body weight (low, medium and high insulin dose). Mean values or proportions of clinical and standard biochemical parameters, as well as hsCRP, pentraxin 3 (PTX 3), nitrotyrosine and endothelin-1 will be compared between 1st and 3rd tertile using ANOVA, Kruskal-Wallis and chi-square tests as appropriate.

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 8288 0
Romania
State/province [1] 8288 0
Cluj

Funding & Sponsors
Funding source category [1] 294621 0
University
Name [1] 294621 0
Iuliu Hatieganu University of Medicine and Pharmacy
Address [1] 294621 0
8 Victor Babes St, Cluj-Napoca, 400006, Romania
Country [1] 294621 0
Romania
Primary sponsor type
Individual
Name
Cornelia Bala
Address
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Diabetes, Nutrition and Metabolic Diseases, 2 Clinicilor St, 400006 Cluj-Napoca, Romania
Country
Romania
Secondary sponsor category [1] 293483 0
None
Name [1] 293483 0
Address [1] 293483 0
Country [1] 293483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296062 0
Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy
Ethics committee address [1] 296062 0
8 Victor Babes St, Cluj-Napoca
Ethics committee country [1] 296062 0
Romania
Date submitted for ethics approval [1] 296062 0
21/03/2016
Approval date [1] 296062 0
20/04/2016
Ethics approval number [1] 296062 0
No 162/20.04.2016

Summary
Brief summary
The study will examine the hypothesis that higher doses of insulin chronically administered to patients with type 2 diabetes are associated with inflammation, oxidative stress and endothelial dysfunction. The study is observational, no intervention will be made on insulin treatment before or during the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69402 0
Dr Cornelia Bala
Address 69402 0
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Diabetes, Nutrition and Metabolic Diseases, 2 Clinicilor St, 400006 Cluj-Napoca, Romania
Country 69402 0
Romania
Phone 69402 0
+40 264 594455
Fax 69402 0
+40 264 594455
Email 69402 0
cbala@umfcluj.ro
Contact person for public queries
Name 69403 0
Dr Cornelia Bala
Address 69403 0
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Diabetes, Nutrition and Metabolic Diseases, 2 Clinicilor St, 400006 Cluj-Napoca, Romania
Country 69403 0
Romania
Phone 69403 0
+40264594455
Fax 69403 0
+40264594455
Email 69403 0
cbala@umfcluj.ro
Contact person for scientific queries
Name 69404 0
Dr Cornelia Bala
Address 69404 0
Iuliu Hatieganu University of Medicine and Pharmacy, Department of Diabetes, Nutrition and Metabolic Diseases, 2 Clinicilor St, 400006 Cluj-Napoca, Romania
Country 69404 0
Romania
Phone 69404 0
+40264594455
Fax 69404 0
+40264594455
Email 69404 0
cbala@umfcluj.ro

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary