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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01474603

Acronym

IMPEDE-DM2

Enrollment

Registered

2011-11-18

Start date

2011-11-30

Completion date

2015-03-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Insulin Resistance, Obese, Overweight

Keywords

observational study

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.

Interventions

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

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
change from baseline of inflammatory and metabolic parameters	3 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026