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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)

This study is currently recruiting participants.
Verified November 2011 by Medical University of Vienna
Sponsor:
Collaborators:
Enervit Srl (company)
Fa. Winkelbauer GmbH (company)
Information provided by (Responsible Party):
Thomas M Stulnig, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01474603
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Overweight
Obese
Insulin Resistance
Diabetes
 Dietary Supplement: n-3 PUFA in protein-enriched low-GI diet

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • HbA1c change from baseline (type 2 diabetes patients) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • body weight change from baseline (non-diabetic patients) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline of inflammatory and metabolic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma samples for biochemical analyses


Estimated Enrollment: 200
Study Start Date: November 2011
Groups/Cohorts Assigned Interventions
1A
overweight (non-obese) insulin-resistant, non-diabetic, non-prediabetic
 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
1B
obese insulin-resistant, non-diabetic, non-prediabetic
 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
2A
overweight (non-obese) prediabetic
 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
2B
obese prediabetic
 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
3A
overweight (non-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
3B
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

overweight to obese insulin resistant, prediabetic and diabetic patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474603

Contacts
Contact: Thomas M Stulnig, MD +43140400 ext 4368 thomas.stulnig@meduniwien.ac.at

Locations
Austria
Dept. Medicine III, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Thomas M Stulnig, MD     +43-1-40400 ext 4368     thomas.stulnig@meduniwien.ac.at    
Sub-Investigator: Bianca K Itariu, MD            
Sub-Investigator: Eva Hochbrugger, MD            
Sub-Investigator: Simone Moosheer            
Sponsors and Collaborators
Medical University of Vienna
Enervit Srl (company)
Fa. Winkelbauer GmbH (company)
  More Information

No publications provided

Responsible Party: Thomas M Stulnig, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01474603     History of Changes
Other Study ID Numbers: IMPEDE-DM2
Study First Received: November 15, 2011
Last Updated: November 17, 2011
Health Authority: Medical University of Vienna, Austria:

Keywords provided by Medical University of Vienna:
observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperinsulinism
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013