Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT02818192

Conditions

Type 2 Diabetes

Proteinuria

Stress

Nephropathy

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Type 2 Diabetes

Proteinuria

Stress

Nephropathy

Study ID

NCT02818192

Start date

Jan, 2017

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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) 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

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Persistent Albuminuria [ Time Frame: 2 years ]
  • Change in albumin excretion over time. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Brandy A Wicklow, MD, MSc

2047871222bwicklow@hsc.mb.ca

Melissa Del Vecchio, MSc

2047893827mdelvecchio@chrim.ca

Locations

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

Recruiting

Winnipeg, Manitoba, Canada, R3E 3P4

Contacts

Brandy A Wicklow, MD, MSc

2047871222bwicklow@hsc.mb.ca

Principal Investigator:

Brandy A Wicklow, MD, MSc

More Information

Sponsor

University of Manitoba

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-06-29.