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

Completed · Phase 2/Phase 3

Conditions studied: Assess the Effect of Green Tea on Diabetes, Assess the Effect of Fermented Papaya Pretration on Diabetes, Effects of Green Tea and FPP on C-reactive Proteins, Effects of Green Tea and FPP of Lipid Profiles in Diabetes, Effect of Green Tea and FPP on Atheroma Formation

In brief

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.

Key facts

Study ID

NCT01248143

Run by

The Touro College and University System

People needed

300

Starts

2010-11-01

Expected to finish

2011-03-01

Last updated by the study team

2014-11-17

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Touro College of Pharmacy — New York, New York, United States
• University of Vienna — Vienna, Austria
• University of Mauritius — Réduit, Mauritius

Full record on ClinicalTrials.gov

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