KCT0002260招募中未知
Hospital-based Diabetes Prevention Study in Korea ; A Prospective, Multi-center, Randomized, Open-label Controlled study
Kyung Hee University Hospital0 个研究点目标入组 744 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 744
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 31(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •1. 30<Age<65
- •2. BMI=23 kg/m2
- •3. '75g OGTT: 140~199 mg/dL' or 'Fasting Blood Sugar 110~125' 'HbA1c 5.7%~6.4%'
排除标准
- •1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
- •2. Type 2 Dibetes Mellitus
- •? Who diagnosed with Diabetes Mellitus except for maternity period.
- •? Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
- •? Fasting Glucose= 126 mg/dL
- •? 2 hours after 75g OGTT = 200 mg/dL
- •? HbA1c = 6.5%
- •3. Who life expectancy is short.
- •? Cardiac history
- •?- History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
- •?- Systolic blood pressure >180 mmHg or Diastolic blood pressure >105 mmHg
- •?- aortic stenosis
- •?- Left bundle branch block or Third degree AV block
- •? Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years
- •? Abnormal renal function (Creatinine = 1.4 mg/dL (male) or = 1.3 mg/dL (female) or Urine Protein = 2 +)
- •? Anemia(Hematocrit <36%((male) or><33%(female)) ? Cirrhosis or chronic active hepatitis (AST/ALT>3UNL)
- •? Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)
- •? Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.
- •? Chronic infection (HIV, active tuberculosis, etc.)
- •? Pulmonary patients who rely on oxygen or daily bronchodilators
- •4. Who is judged to be able to influence the clinical trial by investigator.
- •? Who can not communicate
- •? Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
- •? Those who do not agree to the treatment group allocation by random assignment
- •? Those who participate in other studies that may interfere with the clinical trial
- •? Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
- •? Those who can not have normal walking or exercise
- •? Women who are pregnant
- •? Those who are currently pregnant or who are within the last 3 months after giving birth
- •? Those planning pregnancy during the clinical trial period
- •? Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
- •? Those who are not appropriate or unreliable for clinical trials at the discretion of the tester
- •5.Who taking medication or medical condition that may affect the diagnosis of diabetes
- •? Thiazide diuretics
- •? Systemic beta blockers
- •? Taking Niacinfor the treatment of neutropenic depression
- •? Possibility of taking or injecting a systemic steroid preparation
- •? Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
- •? Taking medicine for weight loss
- •? Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range)
- •(If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
- •? Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
- •? During treatment, fasting plasma triglyceride> 600 mg / d
研究者
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