Effects of Red Grape Cells (RGC) Powder in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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 i.e. 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
    

Intervention name(s): Red Grape Cells (RGC); Placebo (for Red Grape Cells (RGC))
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month; Placebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder
Other intervention name(s): RGC; RGC Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Red Grape Cells powder (RGC); Placebo (PLA)