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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623139
• Other study ID #: H-18014918
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: August 16, 2022

Study information

• Verified date: April 2023
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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