Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

Effects Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

There has been an increase in the prevalance of type 2 diabetes in developed countries in recent years. The major contributing factors have been genetic predisposition, environmental factors, and unhealthy eating habits and stress. Adverse effects on cardiovascular and renal systems after prolonged hyperglycemia bring serious burden to patients, to their families and to the society.

Oxidative stress has been defined as the imbalance between the production of reactive oxygen molecules and antioxidant protective molecules. It has been claimed that oxidative stress that the organism is exposed to and disturbance in anti-oxidant mechanisms have been important in the initiation of diabetes and its complications. Malondialdehyde is the final product of lipid peroxidation and it is an aldehyde as well. It has been accepted that malondialdehyde has been a biomarker in measuring oxidative stress.

Type 2 diabetic people who are between 40 -65 years of age will be the subjects of our study. The levels of fasting glucose, HbA1c, LDL, triglyceride, AST and ALT and also malondialdehyte, hydrogen peroxide and oxidative stress will be determined in patients blood after making them consume a 1500 calory standard diet for 2 weeks, The patients will be randomly divided into two grouos at the end of the two weeks. Group 1 will take placebo in addition to the diet, Group 2 will receive polyphenol containing capsules with pomegranate extract (500 mg), green tea extract (300 mg) and a little bit of (60 mg) vitamin C for three months. At the end of three months the measurement of biochemical parameters will be repeated.

Patients with cardiac, renal, liver disease and smokers will be excluded from the study.

Patients in both groups will have a diet rich in vegetables, three servings of fruit, maximum three slices of bread with a total calory of 1500.

In addition to these, both groups will have a weekly aerobic exercise regimen of 150 minutes conducted after breakfast.

The biochemical results of the two groups will be compared at the end of the experiment and they will be statistically evaluated.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Sisli Etfal Education and Research Hospital
    • Contact: Tayyibe Saler, Dr; Phone Number: (+90 505) 7734300; Email: taybe1970@hotmail.com
    • Contact: Aysen Fenercioglu, Assist Prof. Dr.; Phone Number: (+90 537) 9645751; Email: aysenfenerci@hotmail.com
    • Sub-Investigator: Tayyibe Saler, Dr
    • Principal Investigator: Aysen Fenercioglu, Assist Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 diabetic patients between 40-65 years of age will be eligible for the study

Exclusion Criteria:

• Patients with cardiac, renal, liver disease and smokers will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; We planned to compare a study group of 60 subjects with a placebo group of 60 subjects	Dietary supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C); 1 tablet/day for 3 months; Other Names: Comilac PomGT tablets
Active Comparator: Group 2; We planned to compare a study group of 60 subjects with a placebo group of 60 subjects	Dietary supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C); 1 tablet/day for 3 months; Other Names: Comilac PomGT tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
treatment of type 2 diabetes by polyphenol containing antioxidants	3 months

Collaborators and Investigators

• Sponsor: Yeditepe University Hospital
• Investigators: Principal Investigator: Aysen Fenercioglu, Assist Prof. Dr., Yeditepe University Medical Faculty, Family medicine Department

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (Estimate): May 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 22, 2008
• Last Update Submitted That Met QC Criteria: May 20, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Oxidative stress; diabetes; glutathione; malondialdehyde; polyphenol containing antioxidants; diet rich in vegetables; weekly aerobic exercise
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: DM2-AOC