Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Persistent Albuminuria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All youth with T2D that do not meet
排除标准
- •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
- •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
- •Exclusion Criteria:
- •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
结局指标
主要结局
Persistent Albuminuria
时间窗: 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.
时间窗: 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.
次要结局
- Change in estimated glomerular filtration rate (eGFR) over time.(2 years)
研究者
Dr. Brandy Wicklow
Assistant Professor, Pediatrics and Child Health
University of Manitoba