Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients (IMPEDE-DM2)
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About
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.
Enrollment
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Volunteers
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
Trial design
30 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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