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NCT01248143 · ClinicalTrials.gov registry record · Phase 2
Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
A Phase 2 study, sponsored by The Touro College and University System.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT01248143 is a Phase 2 study that has completed, run by The Touro College and University System. The registered enrollment target is 300 participants.
The verdict
NCT01248143, a Phase 2 study, has completed, sponsored by The Touro College and University System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT Green tea
- DIETARY_SUPPLEMENT FPP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248143
The ClinicalTrials.gov registry entry for NCT01248143 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Touro College and University System, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Green tea is the first listed.
NCT01248143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248143 about?
NCT01248143 is a clinical study titled "Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases". 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 infusa...
What is the current status of trial NCT01248143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2010-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01248143?
The interventions under investigation include: Green tea (DIETARY_SUPPLEMENT), FPP (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01248143?
This trial is sponsored by The Touro College and University System, which has 7 total clinical trials registered on ClinicalTrials.gov.
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