Clinical trial NCT03623139: Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Keywords: carbohydrates
basic carbohydrate counting
diet
type 2 diabetes
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-08-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, 6 months
measure: Change in mean amplitude of glycaemic excursions (MAGE)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 12 months
measure: Change in body weight
timeFrame: Baseline, 6 months, 12 months
measure: Change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, 6 months, 12 months
measure: Change in high-density cholesterol (HDL-C)
timeFrame: Baseline, 6 months, 12 months
measure: Change in total cholesterol (TC)
timeFrame: Baseline, 6 months, 12 months
measure: Change in free fatty acids (FFA)
timeFrame: Baseline, 6 months, 12 months
measure: Change in triglycerides (TG)
timeFrame: Baseline, 6 months, 12 months
measure: Change in diastolic blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Change in systolic blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Change in waist circumference
timeFrame: Baseline, 6 months, 12 months
measure: Change in hip circumference
timeFrame: Baseline, 6 months, 12 months
measure: Change in total fat free mass
timeFrame: Baseline, 6 months
measure: Change in total fat mass
timeFrame: Baseline, 6 months
measure: Change in time in range (3.9-10.0 mmol/l)
timeFrame: Baseline, 6 months
measure: Changes in time spent in hypoglycaemia (<3.9 mmol/l)
timeFrame: Baseline, 6 months
measure: Change time spent in hyperglycaemia (e.g. >11.1 mmol/l)
timeFrame: Baseline, 6 months
measure: Change in standard deviation of mean plasma glucose
timeFrame: Baseline, 6 months
measure: Change in mathematical literacy
timeFrame: Baseline, 6 months, 12 months
measure: Change in carbohydrate estimation accuracy
timeFrame: Baseline, 6 months, 12 months
measure: Change in diet-related quality of life
timeFrame: Baseline, 6 months, 12 months
measure: Change in perceived competences in diabetes
timeFrame: Baseline, 6 months, 12 months
measure: Change in degree of autonomy-supportive dietitian
timeFrame: Baseline, 6 months, 12 months
measure: Change in total energy intake
timeFrame: Baseline, 6 months
measure: Change in dietary intake of carbohydrates
timeFrame: Baseline, 6 months
measure: Change in dietary intake of total fat
timeFrame: Baseline, 6 months
measure: Change in dietary intake of saturated fatty acids (SFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of monounsaturated fatty acids (MUFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of polyunsaturated fatty acids (PUFA)
timeFrame: Baseline, 6 months
measure: Change in dietary intake of protein
timeFrame: Baseline, 6 months
measure: Change in dietary intake of added sugar
timeFrame: Baseline, 6 months
measure: Change in intake of dietary fibre
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in physical activity level
timeFrame: Baseline, 6 months, 12 months
measure: Change in urinary biomarkers of carbohydrate intake
timeFrame: Baseline, 6 months
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Bettina Ewers, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ewers B, Bruun JM, Vilsboll T. Effects of basic carbohydrate counting versus standard outpatient nutritional education (The BCC Study): study protocol for a randomised, parallel open-label, intervention study focusing on HbA1c and glucose variability in patients with type 2 diabetes. BMJ Open. 2019 Nov 21;9(11):e032893. doi: 10.1136/bmjopen-2019-032893.