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

NCT02818192 | Recruiting

• 1 other identifier: B2011:024
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
2. 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. 3.Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
4. 4.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.
5. 5.Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
6. 6.Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.

Conditions

Type 2 Diabetes; Proteinuria; Stress; Nephropathy

Outcome Measures

Primary Outcomes (2)

• Persistent Albuminuria

  Persistent albuminuria Definition: 1. Albumin:creatine (ACR) \> 3.0mg/mmol in at least two urine samples within 6 months at least 1 month apart. 2. ACR \> 3.0mg/mmol with a timed overnight urine or first am urine collection.

  2 years

• Change in albumin excretion over time.

  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.

  2 years

Secondary Outcomes (1)

• Change in estimated glomerular filtration rate (eGFR) over time.

  2 years

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Prevalent youth 10-18 years of age being treated for T2D at 7 pediatric endocrinology clinics across Canada (Stollery Hospital in Edmonton, Alberta Children's Hospital in Calgary, Children's Hospital of Saskatoon, Children's Hospital of Winnipeg, Children's Hospital of Eastern Ontario in Ottawa, SickKids Hospital in Toronto, and the IWK Health Centre in Halifax)

You may not qualify if:

• 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) or
• Hemoglobin A1c value ≥ 6.5%
• 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
• Diabetes secondary to medication use or surgery

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

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

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 25284698 RESULT

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brandy A Wicklow, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandy A Wicklow, MD, MSc

CONTACT

2047871222; bwicklow@hsc.mb.ca

Melissa Del Vecchio, MSc

CONTACT

2047893827; mdelvecchio@chrim.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics and Child Health

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CA (1)