NCT03623139

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

Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Randomized Controlled Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes (The BCC Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard medical and dietary care (control group) or 2) Structured training and education in the BCC concept in addition to standard medical and dietary care. The primary objective is to evaluate the six months effect of structured training and education in the BCC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-28
• Primary completion: 2022-08-16
• Completion: 2022-08-16
• First posted: 2018-08-09
• Last updated: 2023-04-27

Locations

1 site across 1 country: Denmark