MedTrace Logo

POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes

NCT03047668 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-07-22

No results posted yet for this study

Summary

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.

Conditions

Interventions

DIETARY_SUPPLEMENT

diet with/without supplementation

diet with/without supplementation with PUFAs

Sponsors & Collaborators

  • German Center for Diabetes Research

    collaborator OTHER

  • California Walnut Commission

    collaborator OTHER

  • Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)

    collaborator UNKNOWN

  • German Institute of Human Nutrition

    lead OTHER

Principal Investigators

  • Andreas FH Pfeiffer, Prof. Dr. med. · DIfE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047668 on ClinicalTrials.gov