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Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes

NCT03623139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-04-27

No results posted yet for this study

Summary

The aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes.

The study hypothesis is that training and education in the BCC concept will improve glycaemic control either by reducing HbA1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.

Conditions

  • Type2 Diabetes
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders

Interventions

BEHAVIORAL

Standard nutritional education

Routine dietary care consists of three individual consultations with a trained dietitian. The individual guidance will be in accordance with the dietary guidelines in type 2 diabetes.

BEHAVIORAL

Basic carbohydrate counting

The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Bettina Ewers, MSc · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2022-08-16
Completion
2022-08-16

Countries

  • Denmark

Study Locations

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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 NCT03623139 on ClinicalTrials.gov