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临床试验/CTRI/2014/01/004319
CTRI/2014/01/004319招募中未知

Serum selenoprotein P and glutathione peroxidase levels in individuals with prediabetes and their association with insulin resistance and inflammatory markers - SELenium In Prediabetes (SELIP) trial

Research Society for Study of Diabetes in India West Bengal Chapter0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
200

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

  • Individuals with persistent impaired fasting glucose (IFG) (100-125mg/dl) and/or impaired glucose tolerance (IGT) (140-199mg/dl) over 2 oral glucose tolerance tests (OGTTS) done over a week using 75 gram anhydrous glucose were included

排除标准

  • Subjects with diabetes mellitus are excluded, i.e. FPG >= 126 mg/dl or 2-hour plasma glucose >= 200 mg/dl during OGTT,
  • Hyperthyroid patients
  • Medical conditions likely to limit life span and/or increase risk of intervention
  • Cardiovascular disease
  • Hospitalization for treatment of heart disease or stroke in past 6 months
  • New York Heart Association Functional Class > 2
  • Renal disease (creatinine >= 1.6 mg/dl for men or >= 1.5 mg/dl for women
  • Hepatitis, based on history and/or serum ALT greater than 2.5 times the upper limit of normal
  • Recent or significant abdominal surgery
  • Pulmonary disease with dependence on oxygen or daily use of bronchodilators
  • Chronic infection (e.g., HIV, active tuberculosis)
  • Patients with history of selenium supplementation
  • Pregnancy and childbearing
  • Currently pregnant or within 3 months postpartum
  • Currently nursing or within 6 weeks of having completed nursing
  • Medications and medical conditions likely to confound the assessment for diabetes, including
  • Thiazide diuretics at a dose greater than 25 mg/day
  • Non-cardioselective beta-blockers, systemic
  • Niacin (individuals receiving treatment with a statin or fenofibrate will not be excluded as long as the dose has been stable for 3 months prior to randomization)
  • Glucocorticoids, systemic
  • Prescription weight-loss or weight-gain medications

研究者

发起方
Research Society for Study of Diabetes in India West Bengal Chapter

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