Type 2 DiabetesNCT02705430
Effect of EPA-DHA Supplement, Life Style Modification Standard Treatment on Clinical Outcome Lipid Membrane Composition in Type 2 Diabetes
A study testing EPA and DHA capsules of 2 g/day, Stress management phone application (Eco Fusion Mentally) and life style program using a mobile phone (Eco Mentally and NewMe) in people with Type 2 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The aim of the present study is: to examine some of the mechanisms by which a change in life style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this computerized life style regulation reduces the development of diabetic complication in a small population based study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- EPA and DHA capsules of 2 g/day, Stress management phone application (Eco Fusion Mentally) and life style program using a mobile phone (Eco Mentally and NewMe)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jun 2018to Mar 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants between 18-80 years of age.
- Have been diagnosed with type 2 diabetes more than nine months before study entry, and, despite having been given standard dietary advice by dietitian, doctor, or nurse and prescribed oral hypoglycaemic agents, insulin, or both.
- Have persistent unsatisfactory glycaemic control defined as HbA1c more than 7%.
- Participants should have at least two of the following three characteristics:
- Overweight or obesity (body mass index ≥25),
- Hypertension (currently prescribed antihypertensive drugs or blood pressure >140/90 mm Hg despite optimized antihypertensive drug treatment),
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- Dyslipidaemia (currently prescribed lipid modifying drugs) or one or more of:
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- total cholesterol >5.2 mmol/l,
- low density lipoprotein cholesterol >3.5 mmol/l,
- triglycerides >2.0 mmol/l,
- high density lipoprotein cholesterol <1.0 mmol/l (despite optimised lipid modifying drug treatment).
Who cannot join
- Pregnancy
- Serious chronic illness.e.g cancer
- End stage renal failure
- Amputation
- Stroke
- Severe retinal microangiopathy
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- Pancreas transplantation
- HbA1c <7%
- Requires diet only treatment
- They are too busy with work
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin medical center
Petah Tikva
Pierre Singer, Professor, 972544920184, psinger@clalit.org.il
Sornwichate Rattanachaiwong, M.D., 66817318004, srattanamd@gmail.com
About this study
Official title: Effect of EPA-DHA Supplementation, Life Style Modification or Standard Treatment on Clinical Outcome and Lipid Membrane Composition in Type 2 Diabetic Patients: a 3 Months Perspective Randomized Pilot Study.
The aim of the present study is: to examine some of the mechanisms by which a change in life style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this computerized life style regulation reduces the development of diabetic complication in a small population based study.
(The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living -www.eco-fusion.com)
- Conditions
- Type 2 Diabetes
- Being tested
- EPA and DHA capsules of 2 g/day, Stress management phone application (Eco Fusion Mentally), life style program using a mobile phone (Eco Mentally and NewMe), mobile phone
- 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.
EPA and DHA capsules of 2 g/dayDietary supplement
EPA and DHA capsules of 2 g/day
Stress management phone application (Eco Fusion Mentally)Behavioural
Stress management phone application (Eco Fusion Mentally)
life style program using a mobile phone (Eco Mentally and NewMe)Behavioural
life style program using a mobile phone (Eco Mentally and NewMe)
mobile phoneDevice
mobile phone
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Group A will continue their actual therapy (control). |
| B | Experimental | Group B will continue their standard therapy with additional stress management application only using a mobile phone (Eco Fusion Mentally) for 3 months of the study Receives: Behavioral: Stress management phone application (Eco Fusion Mentally); Device: mobile phone |
| C | Experimental | Group C will continue their standard therapy with additional life style program using a mobile phone (Eco Mentally and NewMe) for 3 months of the study Receives: Behavioral: life style program using a mobile phone (Eco Mentally and NewMe); Device: mobile phone |
| D | Experimental | Group D will continue their standard therapy plus additional life style program using a mobile phone with additional supplemental EPA and DHA capsules of 2 g/day to be taken daily for the 3 months of the study Receives: Dietary Supplement: EPA and DHA capsules of 2 g/day; Behavioral: life style program using a mobile phone (Eco Mentally and NewMe); Device: mobile phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c < 7%
To attain individualized HbA1c < 7% goal
Measured: 3 months
Secondary outcomes (5)
Changes in hypoglycaemic drugs (type and dose),
Measured: 3 months
Blood pressure< 140\80 mmHg
Measured: 3 months
Fasting plasma glucose
Measured: 3 months
lipid profile. LDL cholesterol ,100 mg/dL; triglycerides ,150 mg/dL; HDL cholesterol .40 mg/dL for men; HDL cholesterol .50 mg/dL for women.
Measured: 3 months
Lipid membrane fatty acid composition analysis
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 posted10 Mar 2016 (estimated)
- Study start20 Jun 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Singer, Rabin Medical Center
- Investigators
- Pierre Singer, Professor, Principal investigator, Head of General Intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705430
- Sponsor's protocol ID
- 0248-15-RMC
- Status last verified
- Jan 2019
- First submitted
- 6 Mar 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EPA-DHA Supplementation, Life Style Modification or Standard Treatment on Clinical Outcome and Lipid Membrane Composition in Type 2 Diabetic Patients: a 3 Months Perspective Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT02705430
- Acronym / sponsor ID
- 0248-15-RMC
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 10 Mar 2016 (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 the present study is: to examine some of the mechanisms by which a change in life style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this computerized life style regulation reduces the development of diabetic complication in a small population based study.
(The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living -www.eco-fusion.com)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Group A will continue their actual therapy (control). |
| B | Experimental | Behavioral: Stress management phone application (Eco Fusion Mentally), Device: mobile phoneGroup B will continue their standard therapy with additional stress management application only using a mobile phone (Eco Fusion Mentally) for 3 months of the study |
| C | Experimental | Behavioral: life style program using a mobile phone (Eco Mentally and NewMe), Device: mobile phoneGroup C will continue their standard therapy with additional life style program using a mobile phone (Eco Mentally and NewMe) for 3 months of the study |
| D | Experimental | Dietary Supplement: EPA and DHA capsules of 2 g/day, Behavioral: life style program using a mobile phone (Eco Mentally and NewMe), Device: mobile phoneGroup D will continue their standard therapy plus additional life style program using a mobile phone with additional supplemental EPA and DHA capsules of 2 g/day to be taken daily for the 3 months of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants between 18-80 years of age.
- Have been diagnosed with type 2 diabetes more than nine months before study entry, and, despite having been given standard dietary advice by dietitian, doctor, or nurse and prescribed oral hypoglycaemic agents, insulin, or both.
- Have persistent unsatisfactory glycaemic control defined as HbA1c more than 7%.
- Participants should have at least two of the following three characteristics:
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Key exclusion criteria (10 listed)
- Pregnancy
- Serious chronic illness.e.g cancer
- End stage renal failure
- Amputation
- Stroke
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 and DHA capsules of 2 g/dayEPA and DHA capsules of 2 g/day | Dietary supplement | D |
| Stress management phone application (Eco Fusion Mentally)Stress management phone application (Eco Fusion Mentally) | Behavioural | B |
| life style program using a mobile phone (Eco Mentally and NewMe)life style program using a mobile phone (Eco Mentally and NewMe) | Behavioural | C, D |
| mobile phonemobile phone | Device | B, C, D |
Primary outcome
HbA1c < 7%
Time frame: 3 months
To attain individualized HbA1c < 7% goal
5 secondary outcomes
Changes in hypoglycaemic drugs (type and dose),
Time frame: 3 months
Blood pressure< 140\80 mmHg
Time frame: 3 months
Fasting plasma glucose
Time frame: 3 months
lipid profile. LDL cholesterol ,100 mg/dL; triglycerides ,150 mg/dL; HDL cholesterol .40 mg/dL for men; HDL cholesterol .50 mg/dL for women.
Time frame: 3 months
Lipid membrane fatty acid composition analysis
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 9 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Pierre Singer, Professor principal investigator
Head of General Intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA and DHA capsules of 2 g/day, Stress management phone application (Eco Fusion Mentally) and life style program using a mobile phone (Eco Mentally and NewMe) in people with Type 2 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 12 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Singer, Professor (+972-3-9376521, psinger@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c < 7% (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 9 Jan 2019.