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临床试验/NCT01248143
NCT01248143已完成2 期

Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases

The Touro College and University System3 个研究点 分布在 3 个国家目标入组 300 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
300
试验地点
3
主要终点
Assess the effects of green tea and FPP on the levels of C-reactive proteins

研究概览

简要总结

Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals at risk of diabetes 35-65 years of age male or female

排除标准

  • Smokers or those who have stopped smoking 6 months before the study
  • Daily alcoholic intake exceeding 4 standard drinks
  • Post menopausal women currently under hormone replacement treatment
  • Hypertension (>140/90 mm Hg)
  • individuals outside the age range 35-60

结局指标

主要结局

Assess the effects of green tea and FPP on the levels of C-reactive proteins

时间窗: 3 months

The pathophysiology of atherosclerosis and other cardiovascular events have associated inflammatory processes. The levels of plasma high-sensitivity (hs) C-Reactive Protein, an acute phase reactant produced in the liver, known to rise in inflammatory reactions are widely suggested to be a predictor of coronary events; and increased uric acid levels (hyperuricemia) are considered to be a risk factor in many clinical conditions including hypertension, cardiovascular events, diabetes mellitus, stroke, and metabolic syndrome.

次要结局

  • Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes(3 years)

研究者

发起方
The Touro College and University System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Okezie I Aruoma

Professor of Pharmaceutical and Biomedical Sciences

The Touro College and University System

研究点 (3)

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