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

Diabetes Clinical Trial

— IMPEDE-DM2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474603
• Other study ID #: IMPEDE-DM2
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: March 14, 2016
• Start date: November 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Medical University of Vienna, Austria:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Obese
• Overweight

Intervention

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

Locations

Country	Name	City	State
Austria	Dept. Medicine III, Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Enervit Spa (company)

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change from baseline (type 2 diabetes patients)		3 months	No
Primary	body weight change from baseline (non-diabetic patients)		3 months	No
Secondary	change from baseline of inflammatory and metabolic parameters		3 months	No