Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients (IMPEDE-DM2)

March 14, 2016 updated by: Thomas M Stulnig, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Dept. Medicine III, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

overweight to obese insulin resistant, prediabetic and diabetic patients

Description

Inclusion Criteria:

  • overweight or obesity AND
  • insulin resistant OR pre-diabetes OR type 2 diabetes

Exclusion Criteria:

  • 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)
  • clinically significant or insufficiently treated thyroid disease
  • anemia
  • active malignant disease
  • inborn or acquired coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
overweight or obese diabetic
Dietary supplement: n-3 PUFA in protein-enriched low-GI diet
3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change from baseline (type 2 diabetes patients)
Time Frame: 3 months
3 months
body weight change from baseline (non-diabetic patients)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline of inflammatory and metabolic parameters
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Enervit Spa (company)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 15, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 18, 2011

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPEDE-DM2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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