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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
Sex
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
15/11/2016
Actual
11/07/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
5/12/2017
Date of last data collection
Anticipated
15/11/2017
Actual
15/12/2017
Sample size
Target
80
Accrual to date
Final
80
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
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
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
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
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
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


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
SourceTitleYear of PublicationDOI
Dimensions AIThe association study of high-sensitivity C-reactive protein, pentraxin 3, nitrotyrosine, and insulin dose in patients with insulin-treated type 2 diabetes mellitus2018https://doi.org/10.2147/tcrm.s162086
N.B. These documents automatically identified may not have been verified by the study sponsor.