Clinical trial NCT00682149: Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients
Official title: Effects Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Oxidative stress
malondialdehyde
glutathione
diabetes
polyphenol containing antioxidants
diet rich in vegetables
weekly aerobic exercise
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants
timeFrame: 3 months
Secondary outcomes:
measure: treatment of type 2 diabetes by polyphenol containing antioxidants
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Education and Research Hospital
Study officials:
affiliation: Yeditepe University Medical Faculty, Family medicine Department
name: Aysen Fenercioglu, Assist Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: