Skip to main content
OpenTrials
Completed

NCT Number: NCT01474603

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. Medicine III, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 PUFA in protein-enriched low-GI diet

Dietary Supplement

3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet

Primary outcomes

  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 outcomes

  1. change from baseline of inflammatory and metabolic parameters

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Enervit Spa (company)

Registry information

Official study 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

Acronym: IMPEDE-DM2

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Nov 18, 2011
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.