Are high doses of insulin correlated with markers of metabolic stress in patients with type 2 diabetes?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001542482
• Date of registration: 08/11/2016
• Prospective Registration: Yes
• Primary sponsor: Cornelia Bala
• 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?
• Date of first enrolment: 11/07/2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001542482.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Random sample;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Romania

Contacts

• Name: Dr Cornelia Bala

• Name: Dr Cornelia Bala

Key inclusion & exclusion criteria

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.

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



Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

type 2 diabetes;
type 2 diabetes

Metabolic and Endocrine - Diabetes

Intervention(s)

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.

Primary Outcome(s)

hsCRP difference between 1st and 3rd tertile of insulin dose; hsCRP will be measured from plasma blood samples[single measure at enrollment]

Secondary Outcome(s)

comparison of pentraxin 3 between 1st and 3rd tertile of insulin dose; pentraxin will be measured from blood samples[single measure at enrollment]

comparison of endothelin-1 between 1st and 3rd tertile of insulin dose; endothelin will be measured from blood samples [single measure at enrollment]

comparison of nitrotyrosine between 1st and 3rd tertile of insulin dose; nitrotyrosine will be measured from blood samples[single measure at enrolment]

Secondary ID(s)

None

Source(s) of Monetary Support

Iuliu Hatieganu University of Medicine and Pharmacy

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy