Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    400
  • sponsor
    University of Manitoba
Updated on 27 January 2021
diabetes
insulin
hypertension
fasting
type 2 diabetes mellitus
oral glucose tolerance test
insulin resistance
biological factors
renal injury
hyperglycemia
glucose tolerance test
plasma glucose
poor glycaemic control
nephritis
blood glucose tests

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.

Description

The investigators will conduct a case-control study within a two-year, prospective observational cohort study of 400 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.

Details
Condition NIDDM, Diabetes Mellitus, Nephropathy, Proteinuria, Diabetes Mellitus, Type 2, Stress, Diabetes Prevention, Diabetes Mellitus Types I and II, Kidney Disease (Pediatric), Diabetes (Pediatric), Kidney Disease, Diabetes Mellitus Type 2, type 2 diabetes mellitus, renal disease, kidney diseases, kidney disorders, nephrologic disease, kidney disorder, disease, kidney, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Clinical Study IdentifierNCT02818192
SponsorUniversity of Manitoba
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All youth with T2D that do not meet exclusion criteria are eligible for the study
Criteria for Diagnosis of T2D
Diagnosis of diabetes will be made according to the Canadian Diabetes Association criteria. There must be 2 abnormal blood glucose tests on different days OR 1 abnormal blood glucose test + symptoms of diabetes
Fasting plasma glucose of > 7.0 mmol/L or
Random glucose > 11.1mmol/L or
hour glucose > 11.1 mmol/L after a standard oral glucose tolerance test (75g)
Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors
including
Presence of overweight/obesity
Other evidence of insulin resistance (acanthosis nigricans)
Family history of type 2 diabetes (1st degree relative)
Intrauterine exposure to hyperglycemia
Family heritage from a high-risk ethnic group (Indigenous, Hispanic, South Asian, Asian or African descent)
Absence of diabetes associated auto-antibodies
HNF-1 alpha heterozygote or homozygote

Exclusion Criteria

Diabetes secondary to medication use or surgery
Antibodies suggestive of type 1 diabetes
Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers
Ever cancer
Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)
Patient and or caregiver unable or unwilling to provide voluntary informed assent/consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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