NCT02639988终止不适用
Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Time to the addition of a new treatment for type 2 diabetes in months
研究概览
简要总结
The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years)
- •Rheumatoid arthritis fulfilling American College of Rheumatology (ACR )1987 or European League Against Rheumatism (ACR/EULAR) 2010 classification criteria
- •Type 2 diabetes (HbA1c ≥6.5% OR fasting glycemia≥7 mmol/l OR glycemia 120 min after 75 mg glucose ingestion ≥ 11.1 mmol/l OR symptoms of hyperglycemia with glycemia ≥11.1 mmol/l)
- •Affiliated to social security system
- •Adults (>18 years) matched for age, sex and BMI with patients with rheumatoid arthritis
- •Osteoarthritis (knee, hip, spine and hand)
- •Type 2 diabetes with disease duration matched with patients with rheumatoid arthritis
- •Affiliated to social security system
排除标准
- •Patient not able to understand study implication and rules
- •Patient opposed to participate to the study
- •Transient diabetes
- •Gestational diabetes
- •Secondary diabetes
结局指标
主要结局
Time to the addition of a new treatment for type 2 diabetes in months
时间窗: five years
addition of a new treatment includes insulin requirement
次要结局
- Proportion of patients requiring the addition of a new treatment for type 2 diabetes in %(five years)
- Proportion of patients with type 2 diabetes-related acute complications in %(two years)
- Glycated haemoglobin (HbA1c) levels in %(two years)
- Insulin resistance (HOMA-IR), absolute value(two years)
- Proportion of patients requesting insulin in %(two years)
- Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in %(five years)
- Proportion of patients with increased HOMA-IR between 2 visits in %(five years)
研究者
研究点 (1)
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