OverweightIMPEDE-DM2NCT01474603
Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients
An observational study of Overweight and Obese, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight, Obese, Insulin Resistance
- What is being tested?
- n-3 PUFA in protein-enriched low-GI diet
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Mar 2015
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: overweight to obese insulin resistant, prediabetic and diabetic patients
Who may be able to join
- overweight or obesity AND
- insulin resistant OR pre-diabetes OR type 2 diabetes
Who cannot join
- changes in anti-diabetic medication in the lat two months
- acute illness during the last two weeks
- HIV infection
- hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis
- severe or insufficiently treated cardiovascular, renal (GFR-MDRD < 60 ml/min) or pulmonary disease
- Macroproteinuria (> 300 mg/g creatinine)
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- clinically significant or insufficiently treated thyroid disease
- anemia
- active malignant disease
- inborn or acquired coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMpact of n-3 Polyunsaturated Fatty Acids With a Protein-Enriched DiEt With Low Glycemic Index on Metabolic and Inflammatory Parameters in Type 2 Diabetic and Obese Patients: an Observational Pilot Study
Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.
- Conditions
- Overweight, Obese, Insulin Resistance, Diabetes
- Being tested
- n-3 PUFA in protein-enriched low-GI diet
- Keywords
- observational study
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFA in protein-enriched low-GI dietDietary supplement
3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | overweight or obese diabetic Receives: Dietary Supplement: n-3 PUFA in protein-enriched low-GI diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline (type 2 diabetes patients)
Measured: 3 months
body weight change from baseline (non-diabetic patients)
Measured: 3 months
Secondary outcomes (1)
change from baseline of inflammatory and metabolic parameters
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 posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionMar 2015
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 OverweightStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Enervit Spa (company)
- Responsible party
- Principal investigator, Thomas M Stulnig, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474603
- Sponsor's protocol ID
- IMPEDE-DM2
- Acronym
- IMPEDE-DM2
- Status last verified
- Mar 2016
- First submitted
- 15 Nov 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Moosheer SM, Waldschutz W, Itariu BK, Brath H, Stulnig TM. A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Prim Care Diabetes. 2014 Dec;8(4):308-14. doi: 10.1016/j.pcd.2014.02.004. Epub 2014 Mar 19.
PubMed 24656509
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of n-3 Polyunsaturated Fatty Acids With a Protein-Enriched DiEt With Low Glycemic Index on Metabolic and Inflammatory Parameters in Type 2 Diabetic and Obese Patients: an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT01474603
- Acronym / sponsor ID
- IMPEDE-DM2 / IMPEDE-DM2
- Conditions
- Overweight, Obese, Insulin Resistance, Diabetes
- Keywords
- observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Enervit Spa (company)
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 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.
Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Dietary Supplement: n-3 PUFA in protein-enriched low-GI dietoverweight or obese diabetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- overweight to obese insulin resistant, prediabetic and diabetic patients
Key inclusion criteria (2 listed)
- overweight or obesity AND
- insulin resistant OR pre-diabetes OR type 2 diabetes
Key exclusion criteria (10 listed)
- changes in anti-diabetic medication in the lat two months
- acute illness during the last two weeks
- HIV infection
- hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis
- severe or insufficiently treated cardiovascular, renal (GFR-MDRD < 60 ml/min) or pulmonary 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 |
|---|---|---|
| n-3 PUFA in protein-enriched low-GI diet3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet | Dietary supplement | 1 |
Primary outcome
HbA1c change from baseline (type 2 diabetes patients)
Time frame: 3 months
body weight change from baseline (non-diabetic patients)
Time frame: 3 months
1 secondary outcome
change from baseline of inflammatory and metabolic parameters
Time frame: 3 months
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 16 Mar 2016.
- Derived from this study: PubMed 24656509Moosheer SM, Waldschutz W, Itariu BK, Brath H, Stulnig TM. A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Prim Care Diabetes. 2014 Dec;8(4):308-14. doi: 10.1016/j.pcd.2014.02.004. Epub 2014 Mar 19.
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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?
An observational study of Overweight and Obese, run by Medical University of Vienna at 1 site in Austria.
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 2 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 16 Mar 2016. 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 Austria. 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 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?
HbA1c change from baseline (type 2 diabetes patients) (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT01474603, 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 16 Mar 2016.