Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Type2 Diabetes
Conditions
Keywords
carbohydrates, basic carbohydrate counting, diet, type 2 diabetes
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).
Interventions
BEHAVIORALStandard 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.
BEHAVIORALBasic carbohydrate counting
The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
Sponsors
University of Copenhagen
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline, 6 months | mmol/mol |
| Change in mean amplitude of glycaemic excursions (MAGE) | Baseline, 6 months | mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 12 months | mmol/mol |
| 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 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 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 |
| 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 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 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 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 |
| Change in time in range (3.9-10.0 mmol/l) | Baseline, 6 months | percent (%) |
| Change in body weight | Baseline, 6 months, 12 months | kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
Denmark
Outcome results
None listed