Type 2 DiabetesNCT00682149
Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients
A study testing PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C) in people with Type 2 Diabetes, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients between 40-65 years of age will be eligible for the study
Who cannot join
- Patients with cardiac, renal, liver disease and smokers will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Etfal Education and Research Hospital
Istanbul
Tayyibe Saler, Dr, (+90 505) 7734300, taybe1970@hotmail.com
Aysen Fenercioglu, Assist Prof. Dr., (+90 537) 9645751, aysenfenerci@hotmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)
- Keywords
- Oxidative stress, malondialdehyde, glutathione, diabetes, polyphenol containing antioxidants, diet rich in vegetables, weekly aerobic exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)Dietary supplement
Also called Comilac PomGT tablets
1 tablet/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | We planned to compare a study group of 60 subjects with a placebo group of 60 subjects Receives: Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C) |
| Group 2 | Active comparator | We planned to compare a study group of 60 subjects with a placebo group of 60 subjects Receives: Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants
Measured: 3 months
Secondary outcomes (1)
treatment of type 2 diabetes by polyphenol containing antioxidants
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Aysen Fenercioglu, Assist Prof. Dr., Principal investigator, Yeditepe University Medical Faculty, Family medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682149
- Sponsor's protocol ID
- DM2-AOC
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00682149
- Acronym / sponsor ID
- DM2-AOC
- Conditions
- Type 2 Diabetes
- Keywords
- Oxidative stress, malondialdehyde, glutathione, diabetes, polyphenol containing antioxidants, diet rich in vegetables, weekly aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)We planned to compare a study group of 60 subjects with a placebo group of 60 subjects |
| Group 2 | Active comparator | Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)We planned to compare a study group of 60 subjects with a placebo group of 60 subjects |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients between 40-65 years of age will be eligible for the study
Key exclusion criteria (1 listed)
- Patients with cardiac, renal, liver disease and smokers will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)Also: Comilac PomGT tablets1 tablet/day for 3 months | Dietary supplement | Group 1, Group 2 |
Primary outcome
Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants
Time frame: 3 months
1 secondary outcome
treatment of type 2 diabetes by polyphenol containing antioxidants
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysen Fenercioglu, Assist Prof. Dr. principal investigator
Yeditepe University Medical Faculty, Family medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C) in people with Type 2 Diabetes, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysen Fenercioglu, Assist Prof Dr. ((+90 537) 9645751, aysenfenerci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.