MedTrace Logo

Moderate or Extensive Carbohydrate Reduction in Risk Patients

NCT03090074 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-10-15

No results posted yet for this study

Summary

Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:

Randomization with regard to carbohydrate restriction (25-30 E% or \< 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.

Two-hundred patients are recruited and each patient is followed for two years.

Conditions

  • Glucose Metabolism Disorders

Interventions

BEHAVIORAL

Diet regime

Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.

BEHAVIORAL

Type of psychological support

Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2021-03-19
Completion
2021-03-19

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT03090074 on ClinicalTrials.gov