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

This study has suspended participant recruitment.
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: June 5, 2013
Last verified: June 2013
  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:


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
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Dept. Medicine III, Medical University of Vienna
Vienna, Austria, 1090
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: June 5, 2013
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 August 26, 2014