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

Completed

• Conditions: Obese; Insulin Resistance; Diabetes; Overweight
• Interventions: Dietary Supplement: n-3 PUFA in protein-enriched low-GI diet

• Registration Number: NCT01474603
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-18
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• overweight or obesity AND
• insulin resistant OR pre-diabetes OR type 2 diabetes

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	n-3 PUFA in protein-enriched low-GI diet	overweight or obese diabetic

Primary Outcome Measures

Name	Time	Method
body weight change from baseline (non-diabetic patients)	3 months
HbA1c change from baseline (type 2 diabetes patients)	3 months

Secondary Outcome Measures

Name	Time	Method
change from baseline of inflammatory and metabolic parameters	3 months

Trial Locations

Locations (1)

Dept. Medicine III, Medical University of Vienna; 🇦🇹 Vienna, Austria