Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

NCT02459496 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-24

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.

Conditions

Interventions

BEHAVIORAL

dietary consulting and advise

first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines

Sponsors & Collaborators

  • German Center for Diabetes Research

    collaborator OTHER
  • California Walnut Company

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

    collaborator UNKNOWN
  • German Institute of Human Nutrition

    lead OTHER

Principal Investigators

  • Andreas F.H. Pfeiffer, Prof. Dr. med. · German Institute of Human Nutrition

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

Countries

  • Germany

Study Locations

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Entities

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 NCT02459496 on ClinicalTrials.gov