Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01938521
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2013-09-01
Brief Title:
Effects of Red Grape Cells RGC Powder in Type 2 Diabetics
Sponsor:
Tel Aviv University
Organization:
Tel Aviv University
Study Overview
Official Title:
Effects of Red Grape Cells RGC Powder on Glycemic and Lipid Control in Patients With Type 2 Diabetes A Double-blind Randomized Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RGC-T2D
Brief Summary:
The aim of this study is to examine whether the chronic administration during 12 weeks of polyphenols contained in Red Grape Cells RGC powder has an effect on mRNA expression of SIRT1 and Clock Genes on circulating levels of HbA1c lipids blood pressure and on postprandial response of glucose lipids insulin C-peptide and GLP-1 in patients with type 2 diabetes
Detailed Description:
There is a growing body of evidence demonstrating that polyphenols and specially the most investigated Resveratrol contained in the Red Grape Cells RGC exert beneficial effects on several markers of metabolic syndrome ie antioxidant anti-inflammatory anti-atherosclerotic vasodilator and antihypertensive activity
Many of this beneficial metabolic effects of polyphenols occurs via activation of sirtuin-1 or silent information regulator-1 gene SIRT1 This gene is expressed in adipose tissue muscle endothelium peripheral blood cells etc where it plays a pivotal role in the regulation of Circadian Clock Genes CCG involved in glucose lipid metabolism endothelial function etc
By activation of SIRT1 and CCG the polyphenols may influence the circadian secretion of adiponectin insulin asymmetric dimethylarginine ADMA and other hormones that influence insulin sensitivity muscular glucose uptake NO synthesis nocturnal hepatic glucose production lipolisis and endothelial function It was shown in several studies in animals and in clinical studies in subjects with metabolic syndrome that SIRT1 expression and its regulation of the CCG improves insulin sensitivity in skeletal muscle preventing weight gain improves pancreatic beta-cell function enhancing insulin secretion and glucose tolerance It was associated with increased lipolisis in white adipose tissue decreased glycolysis increased fatty acid oxidation in skeletal muscle and with increase Nitric Oxide in the endothelium
Given that polyphenols directly on the clock genes or by enhancing SIRT1 expression appears to counter some of the effects of a high-fat diet obesity and metabolic syndrome by protecting against insulin resistance hyperglycemia and dyslipidemia and endothelial dysfunction
It rise the possibility that the polyphenols contained in Red Grape Cells RGC by activation SIRT1 may also exert beneficial effects in subjects affected by type 2 diabetes
Many of this beneficial metabolic effects of polyphenols occurs via activation of sirtuin-1 or silent information regulator-1 gene SIRT1 This gene is expressed in adipose tissue muscle endothelium peripheral blood cells etc where it plays a pivotal role in the regulation of Circadian Clock Genes CCG involved in glucose lipid metabolism endothelial function etc
By activation of SIRT1 and CCG the polyphenols may influence the circadian secretion of adiponectin insulin asymmetric dimethylarginine ADMA and other hormones that influence insulin sensitivity muscular glucose uptake NO synthesis nocturnal hepatic glucose production lipolisis and endothelial function It was shown in several studies in animals and in clinical studies in subjects with metabolic syndrome that SIRT1 expression and its regulation of the CCG improves insulin sensitivity in skeletal muscle preventing weight gain improves pancreatic beta-cell function enhancing insulin secretion and glucose tolerance It was associated with increased lipolisis in white adipose tissue decreased glycolysis increased fatty acid oxidation in skeletal muscle and with increase Nitric Oxide in the endothelium
Given that polyphenols directly on the clock genes or by enhancing SIRT1 expression appears to counter some of the effects of a high-fat diet obesity and metabolic syndrome by protecting against insulin resistance hyperglycemia and dyslipidemia and endothelial dysfunction
It rise the possibility that the polyphenols contained in Red Grape Cells RGC by activation SIRT1 may also exert beneficial effects in subjects affected by type 2 diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None