Type 2 DiabetesiCARENCT02818192
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
An observational study of Type 2 Diabetes and Proteinuria, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 2 Diabetes, Proteinuria, Stress
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- 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
- 2 hour glucose > 11.1 mmol/L after a standard oral glucose tolerance test (75g) or
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Brandy A Wicklow, MD, MSc, 2047871222, bwicklow@hsc.mb.ca
Brandy A Wicklow, MD, MSc
About this study
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:
- Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
- 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.
- Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Read more
Study Hypotheses include:
- 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.
- Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
- Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Read the 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Proteinuria, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Albuminuria
Persistent albuminuria
Definition:
- Albumin:creatine (ACR) > 3.0mg/mmol in at least two urine samples within 6 months at least 1 month apart.
- ACR > 3.0mg/mmol with a timed overnight urine or first am urine collection.
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Change in estimated glomerular filtration rate (eGFR) over time.
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 iCARE equation. This equation was previously validated for use in the iCARE cohort.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Brandy Wicklow, University of Manitoba
- Investigators
- Brandy A Wicklow, MD, MSc, Principal investigator, University of Manitoba, Children's Hospital Research Institute of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818192
- Sponsor's protocol ID
- B2011:024
- Acronym
- iCARE
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 25284698
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
- ClinicalTrials.gov ID
- NCT02818192
- Acronym / sponsor ID
- iCARE / B2011:024
- Conditions
- Type 2 Diabetes, Proteinuria, Stress, Nephropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
- 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.
- 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:
- 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.
- Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (15 listed)
- All youth with T2D that do not meet exclusion criteria are eligible for the study.
- 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:
- Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors including:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistent Albuminuria
Time frame: 2 years
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.
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.
1 secondary outcome
Change in estimated glomerular filtration rate (eGFR) over time.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 25284698Dart 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.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandy A Wicklow, MD, MSc principal investigator
University of Manitoba, Children's Hospital Research Institute of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Proteinuria, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandy A Wicklow, MD, MSc (2047871222, bwicklow@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Albuminuria (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.