Diabetes MellitusPhase 4EPANCT00817622
Effects of EPA and Vitamin E on Leptin, Adiponectin and Enzymatic Antioxidants in Type 2 DM
A Phase 4 study testing EPA, Vitamin E in people with Diabetes Mellitus, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- EPA, Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Sep 2009
- Phase
- Phase 4
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DM Type II.
- Antidiabetic drug therapy which cannot be stopped.
- History of DM about 2-15 year.
- Age between 30-55 year.
- No History of circulatory, thyroid, pulmonary, liver, kidney, cancer.
Who cannot join
- DM Type I.
- Nephropathy.
- Retinopathy.
- Cancer.
- Thyroid disease.
- Renal failure.
Show all 10Show fewer
- pulmonary disease
- MI.
- CHD.
- Liver disease,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of EPA Alone and Combined With Vitamin E on Blood Leptin, Adiponectin and Enzymatic Antioxidants Levels in Type II Diabetic Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.
Read the detailed description
Randomized, double-blind, placebo-controlled, parallel-group study design After a 12weeks, subjects with type II DM will be randomized to receive either 2000 mg pearl EPA per day plus a double-blinded matching placebo (1 corn oil pearls per day) for 12 weeks OR 400 mg VitE pearl plus double-blinded per day plus a double-blinded matching placebo (4 corn oil pearls per day) for 12 weeks OR 2000 mg pearl EPA per day plus a double-blinded matching 400 mg VitE pearl OR placebo(4corn oil pearls per day plus 1 corn oil pearls per day )for 12 weeks.The total dose of EPA pearl will be 2000 mg per day (with the EPA or matching placebo corn oil doses remaining at 4 pearls per day) and The total dose of VitE pearl will be 400 mg per day (with the VitE or matching placebo corn oil doses remaining at 1 pearls per day).
- Conditions
- Diabetes Mellitus
- Being tested
- EPA, Vitamin E
- Keywords
- diabetes mellitus type 2, EPA, leptin, adiponectin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA, Vitamin EDietary supplement
Also called Plus EPA
EPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo, Placebo :
Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day) Placebo pearl + corn oil 400 mg per day for 12 weeks Receives: Dietary Supplement: EPA, Vitamin E |
| B | Active comparator | EPA, Placebo :
EPA pearls,500 mg QID for 12 Weeks (2000 mg per day),From MINAMINUTRITION Company(Belgium)+ Placebo pearl ,corn oil 400 mg per day for 12 weeks Receives: Dietary Supplement: EPA, Vitamin E |
| C | Placebo comparator | Placebo ,Vitamin E :
Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day)+ Vitamin E pearls, 400 mg from DANA Company(IRAN) per day for 12 weeks Receives: Dietary Supplement: EPA, Vitamin E |
| D | Active comparator | EPA, Vitamin E :
EPA pearls,500 mg QID From MINAMINUTRITION Company(Belgium) for 12 Weeks (2000 mg EPA per day)+ Vitamin E pearls, 400 mg from DANA Company ( IRAN) per day for 12 weeks Receives: Dietary Supplement: EPA, Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in leptin and adiponectin after 12 Weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mahmood Djalali, Professor, Study chair, Tehran University of Medical Sciences, school of Public HealthShokooh Sarbolouki, PhD Student, Principal investigator, Tehran University of Medical Sciences, School of Public HealthAhmad Reza - Dorosti, Ph.D., Study chair, Tehran University of Medical Sciences,School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817622
- Sponsor's protocol ID
- 27-4955
- Acronym
- EPA
- Status last verified
- Nov 2009
- First submitted
- 3 Jan 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarbolouki Sh, Djalali M, Dorosty A, Djazayery S, Eshraghian M, Ebadi S, Hashemi S. Effects of EPA and Vitamin E on Serum Enzymatic Antioxidants and Peroxidation Indices in Patients with Type II Diabetes Mellitus. Iran J Public Health. 2010;39(3):82-91. Epub 2010 Sep 30.
PubMed 23113026
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EPA Alone and Combined With Vitamin E on Blood Leptin, Adiponectin and Enzymatic Antioxidants Levels in Type II Diabetic Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00817622
- Acronym / sponsor ID
- EPA / 27-4955
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus type 2, EPA, leptin, adiponectin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Jan 2009 (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.
The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.
Detailed description
Randomized, double-blind, placebo-controlled, parallel-group study design After a 12weeks, subjects with type II DM will be randomized to receive either 2000 mg pearl EPA per day plus a double-blinded matching placebo (1 corn oil pearls per day) for 12 weeks OR 400 mg VitE pearl plus double-blinded per day plus a double-blinded matching placebo (4 corn oil pearls per day) for 12 weeks OR 2000 mg pearl EPA per day plus a double-blinded matching 400 mg VitE pearl OR placebo(4corn oil pearls per day plus 1 corn oil pearls per day )for 12 weeks.The total dose of EPA pearl will be 2000 mg per day (with the EPA or matching placebo corn oil doses remaining at 4 pearls per day) and The total dose of VitE pearl will be 400 mg per day (with the VitE or matching placebo corn oil doses remaining at 1 pearls per day).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Dietary Supplement: EPA, Vitamin EPlacebo, Placebo : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day) Placebo pearl + corn oil 400 mg per day for 12 weeks |
| B | Active comparator | Dietary Supplement: EPA, Vitamin EEPA, Placebo : EPA pearls,500 mg QID for 12 Weeks (2000 mg per day),From MINAMINUTRITION Company(Belgium)+ Placebo pearl ,corn oil 400 mg per day for 12 weeks |
| C | Placebo comparator | Dietary Supplement: EPA, Vitamin EPlacebo ,Vitamin E : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day)+ Vitamin E pearls, 400 mg from DANA Company(IRAN) per day for 12 weeks |
| D | Active comparator | Dietary Supplement: EPA, Vitamin EEPA, Vitamin E : EPA pearls,500 mg QID From MINAMINUTRITION Company(Belgium) for 12 Weeks (2000 mg EPA per day)+ Vitamin E pearls, 400 mg from DANA Company ( IRAN) per day for 12 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DM Type II.
- Antidiabetic drug therapy which cannot be stopped.
- History of DM about 2-15 year.
- Age between 30-55 year.
- No History of circulatory, thyroid, pulmonary, liver, kidney, cancer.
Key exclusion criteria (10 listed)
- DM Type I.
- Nephropathy.
- Retinopathy.
- Cancer.
- Thyroid disease.
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 |
|---|---|---|
| EPA, Vitamin EAlso: Plus EPAEPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks | Dietary supplement | A, B, C, D |
Primary outcome
Changes in leptin and adiponectin after 12 Weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
- Derived from this study: PubMed 23113026Sarbolouki Sh, Djalali M, Dorosty A, Djazayery S, Eshraghian M, Ebadi S, Hashemi S. Effects of EPA and Vitamin E on Serum Enzymatic Antioxidants and Peroxidation Indices in Patients with Type II Diabetes Mellitus. Iran J Public Health. 2010;39(3):82-91. Epub 2010 Sep 30.
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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.
Mahmood Djalali, Professor study chair
Tehran University of Medical Sciences, school of Public Health
Shokooh Sarbolouki, PhD Student principal investigator
Tehran University of Medical Sciences, School of Public Health
Ahmad Reza - Dorosti, Ph.D. study chair
Tehran University of Medical Sciences,School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EPA, Vitamin E in people with Diabetes Mellitus, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 2009. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in leptin and adiponectin after 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817622, which also lists 1 linked publication.
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 18 Nov 2009.