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

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ClinicalTrials.gov Identifier: NCT02818192
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Brandy Wicklow, University of Manitoba

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.

Condition or disease
Type 2 Diabetes Proteinuria Stress Nephropathy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Persistent Albuminuria [ Time Frame: 2 years ]

    Persistent albuminuria

    Definition:

    1. Albumin:creatine (ACR) > 2.0mg/mmol in at least two urine samples within 6 months at least 1 month apart.
    2. ACR > 2.0mg/mmol with a timed overnight urine or first am urine collection.

  2. Change in albumin excretion over time. [ Time Frame: 2 years ]
    Change in albumin excretion over 2 years. The change in albumin:creatinine ratio, treated as a continuous outcome measure was selected as a valid evaluation of progression of renal injury over time.


Secondary Outcome Measures :
  1. Change in estimated glomerular filtration rate (eGFR) over time. [ Time Frame: 2 years ]

    This outcome will be exploratory as significant changes are not expected during a 2-year follow-up period. However, as GFR reflects actual kidney function, this outcome will become increasingly important as chronic kidney disease (CKD) progresses in the cohort over time. GFR will be determined with serum creatinine measurements, utilizing a new eGFR formula for overweight youth, which have been validated utilizing iohexol GFR data from the initial cohort.

    eGFR will be calculated with the pediatric Schwartz formula and iCARE equation. This equation was previously validated for use in the iCARE cohort.



Biospecimen Retention:   Samples With DNA
Serum, plasma, random urine and buffy coat for DNA extraction will be collected at the baseline visit on all recruited patients that consent to biobanking such that future ancillary studies can be performed. Samples will be processed and frozen at -80 °C, and will be stored for up to 25 years with participant consent. Tests that may be run on stored samples include metabolomics, peptidomics, proteomics, and podocyte microparticle analyses should additional funding be obtained. Samples will be collected at each site and frozen. Periodically samples will be sent to the Canadian Biosample Repository at the University of Alberta for long term storage.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prevalent youth 10-18 years of age being treated for T2D at 9 pediatric endocrinology clinics across Canada (B.C. Children's in Vancouver, Stollery Hospital in Edmonton, Alberta Children's Hospital in Calgary, Children's Hospital of Winnipeg, McMaster Children's Hospital in Hamilton, Children's Hospital of Eastern Ontario in Ottawa, SickKids Hospital in Toronto, McGill University Health Centre in Montreal and the IWK Health Centre in Halifax)
Criteria

Inclusion Criteria:

  • All youth with T2D that do not meet exclusion criteria are eligible for the study.

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).
  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

Exclusion Criteria:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818192


Contacts
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Contact: Brandy A Wicklow, MD, MSc 2047871222 bwicklow@hsc.mb.ca
Contact: Melissa Gabbs, MSc 2047893827 MGabbs@chrim.ca

Locations
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Canada, Manitoba
Children's Hospital Research Institute of Manitoba/University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Brandy A Wicklow, MD, MSc    2047871222    bwicklow@hsc.mb.ca   
Principal Investigator: Brandy A Wicklow, MD, MSc         
Principal Investigator: Allison Dart, MD, MSc         
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Brandy A Wicklow, MD, MSc University of Manitoba, Children's Hospital Research Institute of Manitoba
Publications of Results:
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Responsible Party: Dr. Brandy Wicklow, Assistant Professor, Pediatrics and Child Health, University of Manitoba
ClinicalTrials.gov Identifier: NCT02818192    
Other Study ID Numbers: B2011:024
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is a multi-site trial where the use and compilation of individual level data is being discussed amongst the various ethics boards across Canada.
Additional relevant MeSH terms:
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Proteinuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations