CTRI/2010/091/001185已完成未知
Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
ational Heart Lung and Blood Institute National Institutes for Heath USA0 个研究点目标入组 1,146 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 35 years and older
- •2. Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin
- •3. Poor glycemic control (as evidenced by HbA1c greater than or equal to 8.0%) AND one or both of: dyslipidemia (LDL greater than or equal to 130 mg/dl) or systolic hypertension (SBP greater than or equal to 140 mmHg), irrespective of lipid- or BP-lowering medication use, respectively
- •4. Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigators assessment the patient is likely to follow-up regularly as required by the protocol.
- •5. Willingness to consent to randomization
- •Note- The trial has no upper age limit.
排除标准
- •Individuals will be excluded from participation if any of the following are present during screening:
- •1. Known type 1 diabetes mellitus
- •2. Diabetes secondary to chronic pancreatitis
- •3. Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth
- •control (including natural methods)
- •4. Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as
- •evidenced by HbA1c < 7.0%, SBP < 130 mmHg, LDL-cholesterol < 100 mg/dl [LDL-cholesterol < 70
- •mg/dl with history of CVD event]) obtained from screening within a period not exceeding 28 days (4
- •weeks) prior to randomization
- •5. Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12
- •6. Current symptomatic CHF or NYHA Class 3 or 4 effort intolerance
- •7. Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant])
- •8. Transaminase >3 times upper limit of normal OR active liver disease within past 2 years
- •9. Malignancy or life-threatening disease with death probable in 4 years
- •10. Any current medication (e.g. long-term steroids, protease inhibitors) that, in the opinion of the site investigator, would interfere with participant?s diabetic status and follow-up
- •11. Any condition or circumstance that is unrelated to diabetes progression, that in the opinion of the site investigator would interfere with the participant?s diabetic status and follow-up: including (but not limited to) other endocrinopathy [adrenal, pituitary], TB patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, BMI >= 45 kg/m2
- •12. On an investigational drug in the last 3 months
- •13. Currently participating in a clinical trial
- •14. No fixed address or contact details
- •15. Plans to move in the next 3 years
- •16. A member of the participant?s household is currently in the trial
- •17. Inability or unwillingness of individual or legal guardian /representative to give written informed consent
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