Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-02-02 @ 5:11 AM
Study NCT ID:
NCT02818192
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iCARE
Brief Summary:
The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they cause renal injury. The Study aims include:
1. Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
2. Determine individual, family and community level factors that influence biological and psychological risk factors and behaviors (adherence) that could be modified to protect against prevalent and progressive albuminuria.
3. Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Study Hypotheses include:
1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and psychological and social adversity (stress, mental distress and poverty) are significant predictors of prevalent and progressive albuminuria in youth with T2D.
2. Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
3. Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
1. Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
2. Determine individual, family and community level factors that influence biological and psychological risk factors and behaviors (adherence) that could be modified to protect against prevalent and progressive albuminuria.
3. Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Study Hypotheses include:
1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and psychological and social adversity (stress, mental distress and poverty) are significant predictors of prevalent and progressive albuminuria in youth with T2D.
2. Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
3. Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Detailed Description:
The investigators will conduct a case-control study within a two-year, prospective observational cohort study of 500 prevalent cases of T2D diagnosed \<18 years of age. The investigators will evaluate the primary BPS risk factors associated with prevalent albuminuria using a principal component analysis (PCA) of associations between primary exposure variables at enrollment. After confirming the relevant BPS factors in the PCA analysis, the investigators will utilize a structural equation modeling approach to confirm the developed model.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: