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

Sponsor

Steno Diabetes Center Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03623139

Collaborator

University of Copenhagen (Other)

226

Enrollment

Location

Arms

87.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Diabetes Mellitus, Type 2 Glucose Metabolism Disorders	Behavioral: Standard nutritional education Behavioral: Basic carbohydrate counting	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Sep 28, 2018

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard nutritional education Control group	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. Other Names: Routine dietary care in type 2 diabetes
Experimental: BCC Education and training i basic carbohydrate counting (BCC) plus standard nutritional education	Behavioral: Basic carbohydrate counting The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians. Other Names: Education in BCC in addition to standard dietary care

Arm

Intervention/Treatment

Active Comparator: Standard nutritional education

Control group

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.

Other Names:

Routine dietary care in type 2 diabetes

Experimental: BCC

Education and training i basic carbohydrate counting (BCC) plus standard nutritional education

Behavioral: Basic carbohydrate counting

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

Other Names:

Education in BCC in addition to standard dietary care

Outcome Measures

Primary Outcome Measures

Change in HbA1c [Baseline, 6 months]
mmol/mol
Change in mean amplitude of glycaemic excursions (MAGE) [Baseline, 6 months]
mmol/l

Secondary Outcome Measures

Change in HbA1c [12 months]
mmol/mol
Change in body weight [Baseline, 6 months, 12 months]
kg
Change in low-density lipoprotein cholesterol (LDL-C) [Baseline, 6 months, 12 months]
mmol/l
Change in high-density cholesterol (HDL-C) [Baseline, 6 months, 12 months]
mmol/l
Change in total cholesterol (TC) [Baseline, 6 months, 12 months]
mmol/l
Change in free fatty acids (FFA) [Baseline, 6 months, 12 months]
mmol/l
Change in triglycerides (TG) [Baseline, 6 months, 12 months]
mmol/l
Change in diastolic blood pressure [Baseline, 6 months, 12 months]
mm Hg
Change in systolic blood pressure [Baseline, 6 months, 12 months]
mm Hg
Change in waist circumference [Baseline, 6 months, 12 months]
cm
Change in hip circumference [Baseline, 6 months, 12 months]
cm
Change in total fat free mass [Baseline, 6 months]
gram
Change in total fat mass [Baseline, 6 months]
gram
Change in time in range (3.9-10.0 mmol/l) [Baseline, 6 months]
percent (%)
Changes in time spent in hypoglycaemia (<3.9 mmol/l) [Baseline, 6 months]
percent (%)
Change time spent in hyperglycaemia (e.g. >11.1 mmol/l) [Baseline, 6 months]
percent (%)
Change in standard deviation of mean plasma glucose [Baseline, 6 months]
mmol/l
Change in mathematical literacy [Baseline, 6 months, 12 months]
total score or percent (%)
Change in carbohydrate estimation accuracy [Baseline, 6 months, 12 months]
total score or %
Change in diet-related quality of life [Baseline, 6 months, 12 months]
total score or percent (%)
Change in perceived competences in diabetes [Baseline, 6 months, 12 months]
total score or percent (%)
Change in degree of autonomy-supportive dietitian [Baseline, 6 months, 12 months]
total score or percent (%)
Change in total energy intake [Baseline, 6 months]
kJ/day
Change in dietary intake of carbohydrates [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of total fat [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of saturated fatty acids (SFA) [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of monounsaturated fatty acids (MUFA) [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of polyunsaturated fatty acids (PUFA) [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of protein [Baseline, 6 months]
gram/day or percent of total energy (E%)
Change in dietary intake of added sugar [Baseline, 6 months]
gram/day , % of total energy or %
Change in intake of dietary fibre [Baseline, 6 months]
gram/day or g/MJ

Other Outcome Measures

Change in physical activity level [Baseline, 6 months, 12 months]
total score or percent (%)
Change in urinary biomarkers of carbohydrate intake [Baseline, 6 months]
percent (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes
Diabetes duration; from >12 months
HbA1c between 53 and 97 mmol/mol
Diet or any glucose-lowering medication
Provided voluntary written informed consent

Exclusion Criteria:

Practicing carbohydrate counting, as judged by the investigator
Participated in a BCC group program within the last two years
Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
Use of open CGM
Use of a Free Libre device
Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator
Gastroparesis
Pregnancy or breastfeeding, or plans of pregnancy within the study period
Uncontrolled medical issues, as judged by the investigator
Concomitant participation in other clinical studies
Unable to understand the informed consent and the study procedures