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Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Yeditepe University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yeditepe University Hospital
ClinicalTrials.gov Identifier:
NCT00682149
First received: May 20, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Yeditepe University Hospital:

Primary Outcome Measures:
  • Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • treatment of type 2 diabetes by polyphenol containing antioxidants [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Comilac PomGT tablets

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682149

Contacts
Contact: Aysen Fenercioglu, Assist Prof Dr. (+90 537) 9645751 aysenfenerci@hotmail.com
Contact: Ece Genc, Prof. Dr. (+90 535) 2178145 egenc@yeditepe.edu.tr

Locations
Turkey
Sisli Etfal Education and Research Hospital Recruiting
Istanbul, Turkey
Contact: Tayyibe Saler, Dr    (+90 505) 7734300    taybe1970@hotmail.com   
Contact: Aysen Fenercioglu, Assist Prof. Dr.    (+90 537) 9645751    aysenfenerci@hotmail.com   
Sub-Investigator: Tayyibe Saler, Dr         
Principal Investigator: Aysen Fenercioglu, Assist Prof. Dr.         
Sponsors and Collaborators
Yeditepe University Hospital
Investigators
Principal Investigator: Aysen Fenercioglu, Assist Prof. Dr. Yeditepe University Medical Faculty, Family medicine Department
  More Information

No publications provided

Responsible Party: Effects of polyphenol containing antioxidants on oxidative stress in type 2 diabetic patients, Yeditepe University Medical Faculty, Family Medicine Department
ClinicalTrials.gov Identifier: NCT00682149     History of Changes
Other Study ID Numbers: DM2-AOC
Study First Received: May 20, 2008
Last Updated: May 20, 2008
Health Authority: Turkey: Ethics Committee

Keywords provided by Yeditepe University Hospital:
Oxidative stress
malondialdehyde
glutathione
diabetes
polyphenol containing antioxidants
diet rich in vegetables
weekly aerobic exercise

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 24, 2014