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Trial record 1 of 1 for:    NCT01474603
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Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients (IMPEDE-DM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01474603
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : March 16, 2016
Enervit Spa (company)
Information provided by (Responsible Party):
Thomas M Stulnig, Medical University of Vienna

Brief 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 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.

Condition or disease Intervention/treatment
Overweight Obese Insulin Resistance Diabetes Dietary Supplement: n-3 PUFA in protein-enriched low-GI diet

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : November 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. HbA1c change from baseline (type 2 diabetes patients) [ Time Frame: 3 months ]
  2. body weight change from baseline (non-diabetic patients) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. change from baseline of inflammatory and metabolic parameters [ Time Frame: 3 months ]

Biospecimen Retention:   Samples Without DNA
serum and plasma samples for biochemical analyses

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
overweight to obese insulin resistant, prediabetic and diabetic patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01474603

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Dept. Medicine III, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Enervit Spa (company)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas M Stulnig, Associate Professor, Medical University of Vienna Identifier: NCT01474603     History of Changes
Other Study ID Numbers: IMPEDE-DM2
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Thomas M Stulnig, Medical University of Vienna:
observational study
Additional relevant MeSH terms:
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Insulin Resistance
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases