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

NCT ID: NCT02818192

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Type 2 Diabetes; Proteinuria; Stress; Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Exclusion Criteria

Criteria for Diagnosis of T2D:

1. 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
• 2 hour glucose > 11.1 mmol/L after a standard oral glucose tolerance test (75g) or
• Hemoglobin A1c value ≥ 6.5%

2. 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

1. Diabetes secondary to medication use or surgery

2. Antibodies suggestive of type 1 diabetes

3. Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers

4. Ever cancer

5. Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)

6. Patient and or caregiver unable or unwilling to provide voluntary informed assent/consent

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Brandy Wicklow

Assistant Professor, Pediatrics and Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandy A Wicklow, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Children's Hospital Research Institute of Manitoba

Locations

Children's Hospital Research Institute of Manitoba/University of Manitoba

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Brandy A Wicklow, MD, MSc

Role: CONTACT

bwicklow@hsc.mb.ca

2047871222

Melissa Del Vecchio, MSc

Role: CONTACT

mdelvecchio@chrim.ca

2047893827

Facility Contacts

Brandy A Wicklow, MD, MSc

Role: primary

bwicklow@hsc.mb.ca

2047871222

References

Dart AB, Wicklow BA, Sellers EA, Dean HJ, Malik S, Walker J, Chateau D, Blydt-Hansen TD, McGavock JM; iCARE investigators. The Improving Renal Complications in Adolescents With Type 2 Diabetes Through the REsearch (iCARE) Cohort Study: rationale and Protocol. Can J Diabetes. 2014 Oct;38(5):349-55. doi: 10.1016/j.jcjd.2014.07.224.

Reference Type: RESULT

PMID: 25284698 (View on PubMed)

Other Identifiers

B2011:024

Identifier Type: -

Identifier Source: org_study_id