Type 2 DiabetesPhase 4NCT01478776
The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics
A Phase 4 study testing omega-3 in people with Type 2 Diabetes, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Dec 2011to Sep 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- literate
- Willingness to participation
- Diabetic patients 30-65 years old
- Body mass index in the range 18.5-40
- Avoidance of dietary supplements
- vitamins and herbal products at least 2 weeks before and throughout the intervention
Who cannot join
- people who have used omega-3 supplements in last 3 months
- Having chronic renal disease
- hepatic disease
- gastrointestinal disease
- hematological disorders
- hypothyroidism or hyperthyroidism
Show all 9Show fewer
- Treatment with Orlistat or sibutramine for weight loss
- Pregnancy and lactation
- Treatment with insulin or Thiazolidinediones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2
The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics
Read the detailed description
Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.
- Conditions
- Type 2 Diabetes
- Being tested
- omega-3, placebo
- Keywords
- ASP, LCN2, RBP4, C5L2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Dietary supplement
Also called n-3 fatty acids,n-3 PUFA
4 cap 1 gr omega-3 per day for 10 weeks
placeboDietary supplement
patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| diabetes, omega-3 | Active comparator | patient with type 2 diabetes who receive 4gr/day omega-3 Receives: Dietary Supplement: omega-3 |
| placebo, diabetes | Placebo comparator | patient with type 2 diabetes who receive 4 cap of placebo/day Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum total cholesterol
Measured: change from baseline at 10 weeks
serum High-density lipoprotein (HDL) cholesterol
Measured: change from baseline at 10 weeks
serum Low-density lipoprotein (LDL) cholesterol
Measured: change from baseline at 10 weeks
serum triglycerides (TG) level
Measured: change from baseline at 10 weeks
postprandial triglycerides
Measured: change from baseline at 10 weeks
complete blood count(CBC)
Measured: change from baseline at 10 weeks
fasting plasma glucose(FPG)
Measured: change from baseline at 10 weeks
Glycated hemoglobin (Hb A1c)
Measured: change from baseline at 10 weeks
acylation stimulating protein (ASP)
Measured: change from baseline at 10 weeks
lipocalin-2 (LCN2)
Measured: change from baseline at 10 weeks
Retinol-binding protein 4 (RBP4)
Measured: change from baseline at 10 weeks
non-esterified fatty acids (NEFA)
Measured: change from baseline at 10 weeks
insulin
Measured: change from baseline at 10 weeks
postprandial ASP
Measured: chage from baseline at 10 weeks
Secondary outcomes (1)
gene expression of C5L2
Measured: change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013 (estimated)
- Study completionSep 2013 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478776
- Sponsor's protocol ID
- 15176
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2011
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2
- ClinicalTrials.gov ID
- NCT01478776
- Acronym / sponsor ID
- 15176
- Conditions
- Type 2 Diabetes
- Keywords
- ASP, LCN2, RBP4, C5L2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 23 Nov 2011 (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 aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics
Detailed description
Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes, omega-3 | Active comparator | Dietary Supplement: omega-3patient with type 2 diabetes who receive 4gr/day omega-3 |
| placebo, diabetes | Placebo comparator | Dietary Supplement: placebopatient with type 2 diabetes who receive 4 cap of placebo/day |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- literate
- Willingness to participation
- Diabetic patients 30-65 years old
- Body mass index in the range 18.5-40
- Avoidance of dietary supplements
Key exclusion criteria (9 listed)
- people who have used omega-3 supplements in last 3 months
- Having chronic renal disease
- hepatic disease
- gastrointestinal disease
- hematological disorders
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 |
|---|---|---|
| omega-3Also: n-3 fatty acids,n-3 PUFA4 cap 1 gr omega-3 per day for 10 weeks | Dietary supplement | diabetes, omega-3 |
| placebopatient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks | Dietary supplement | placebo, diabetes |
Primary outcome
serum total cholesterol
Time frame: change from baseline at 10 weeks
serum High-density lipoprotein (HDL) cholesterol
Time frame: change from baseline at 10 weeks
serum Low-density lipoprotein (LDL) cholesterol
Time frame: change from baseline at 10 weeks
serum triglycerides (TG) level
Time frame: change from baseline at 10 weeks
postprandial triglycerides
Time frame: change from baseline at 10 weeks
complete blood count(CBC)
Time frame: change from baseline at 10 weeks
fasting plasma glucose(FPG)
Time frame: change from baseline at 10 weeks
Glycated hemoglobin (Hb A1c)
Time frame: change from baseline at 10 weeks
acylation stimulating protein (ASP)
Time frame: change from baseline at 10 weeks
lipocalin-2 (LCN2)
Time frame: change from baseline at 10 weeks
Retinol-binding protein 4 (RBP4)
Time frame: change from baseline at 10 weeks
non-esterified fatty acids (NEFA)
Time frame: change from baseline at 10 weeks
insulin
Time frame: change from baseline at 10 weeks
postprandial ASP
Time frame: chage from baseline at 10 weeks
1 secondary outcome
gene expression of C5L2
Time frame: change from baseline at 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 omega-3 in people with Type 2 Diabetes, 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 6 inclusion and 9 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 3 Dec 2012. 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?
Results are not available in the source record.
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?
serum total cholesterol (time frame: change from baseline at 10 weeks). The study lists 14 primary outcomes in all. 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 3 Dec 2012.