Type 2 DiabetesNCT00371982
Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women
A study testing Fish oil (Maxepa) in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women. 2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Fish oil (Maxepa)
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2002to Apr 2005
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetic postmenopausal women
- glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
- plasma triglycerides between 1.72-4.6 mmol/l,
- aged between 40 -60,
- BMI: 27-40 kg/m2
- able to swallow tablets
Who cannot join
- patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
- patients with gastrointestinal disorders
- patients treated with thiazolidinediones or insulin
Trial locations and contacts
1 site in 1 country.
About this study
- whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
- n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.
Read the detailed description
Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.
- Conditions
- Type 2 Diabetes
- Being tested
- Fish oil (Maxepa)
- Keywords
- Fish oil, Type 2 diabetic women, adiposity, adipose tissue inflammation, PAI-1, Insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil (Maxepa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of 2 month treatment on:
adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity
Secondary outcomes (2)
the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startDec 2002
- Study completionApr 2005
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Salwa W Rizkalla, MD,PhD, Study director, INSERM (National institution of Health and Medical Research)Gerard Slama, MD, professor, Study chair, Public Assistance-Paris Hospitals (AP-HP), University Paris 6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371982
- Sponsor's protocol ID
- INSERM-237-6900, Paris 6-069
- Status last verified
- Nov 2002
- First submitted
- 1 Sep 2006
- Last updated
- 4 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women
- ClinicalTrials.gov ID
- NCT00371982
- Acronym / sponsor ID
- INSERM-237-6900, Paris 6-069
- Conditions
- Type 2 Diabetes
- Keywords
- Fish oil, Type 2 diabetic women, adiposity, adipose tissue inflammation, PAI-1, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Dec 2002
- Study completion
- Apr 2005
- First posted
- 4 Sep 2006 (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.
- whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
- n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.
Detailed description
Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 2 diabetic postmenopausal women
- glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
- plasma triglycerides between 1.72-4.6 mmol/l,
- aged between 40 -60,
- BMI: 27-40 kg/m2
Key exclusion criteria (3 listed)
- patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
- patients with gastrointestinal disorders
- patients treated with thiazolidinediones or insulin
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 |
|---|---|---|
| Fish oil (Maxepa) | Drug | – |
Primary outcome
The effect of 2 month treatment on:
adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity
2 secondary outcomes
the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2006.
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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.
Salwa W Rizkalla, MD,PhD study director
INSERM (National institution of Health and Medical Research)
Gerard Slama, MD, professor study chair
Public Assistance-Paris Hospitals (AP-HP), University Paris 6
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil (Maxepa) in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 4 Sep 2006. 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 France. 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. 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?
The study was stopped early. 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?
The effect of 2 month treatment on:. The study lists 2 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 4 Sep 2006; AzTrials last refreshed its copy on 8 Nov 2026.