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

NCT ID: NCT01474603

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-03-31

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.

Conditions

Overweight; Obese; Insulin Resistance; Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

overweight or obese diabetic

n-3 PUFA in protein-enriched low-GI diet

Intervention Type: DIETARY_SUPPLEMENT

3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enervit Spa (company)

UNKNOWN

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Thomas M Stulnig

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept. Medicine III, Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

Moosheer SM, Waldschutz W, Itariu BK, Brath H, Stulnig TM. A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Prim Care Diabetes. 2014 Dec;8(4):308-14. doi: 10.1016/j.pcd.2014.02.004. Epub 2014 Mar 19.

Reference Type: DERIVED

PMID: 24656509 (View on PubMed)

Other Identifiers

IMPEDE-DM2

Identifier Type: -

Identifier Source: org_study_id