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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard nutritional education | Active Comparator | Control group |
|
| BCC | Experimental | Education and training i basic carbohydrate counting (BCC) plus standard nutritional education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard nutritional education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | mmol/mol | Baseline, 6 months |
| Change in mean amplitude of glycaemic excursions (MAGE) | mmol/l | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | mmol/mol | 12 months |
| Change in body weight | kg | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity level | total score or percent (%) | Baseline, 6 months, 12 months |
| Change in urinary biomarkers of carbohydrate intake | percent (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Ewers, MSc | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | DK-2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31753900 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Apr 25, 2023 |
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|
| Basic carbohydrate counting | Behavioral | The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians. |
|
|
| Change in low-density lipoprotein cholesterol (LDL-C) | mmol/l | Baseline, 6 months, 12 months |
| Change in high-density cholesterol (HDL-C) | mmol/l | Baseline, 6 months, 12 months |
| Change in total cholesterol (TC) | mmol/l | Baseline, 6 months, 12 months |
| Change in free fatty acids (FFA) | mmol/l | Baseline, 6 months, 12 months |
| Change in triglycerides (TG) | mmol/l | Baseline, 6 months, 12 months |
| Change in diastolic blood pressure | mm Hg | Baseline, 6 months, 12 months |
| Change in systolic blood pressure | mm Hg | Baseline, 6 months, 12 months |
| Change in waist circumference | cm | Baseline, 6 months, 12 months |
| Change in hip circumference | cm | Baseline, 6 months, 12 months |
| Change in total fat free mass | gram | Baseline, 6 months |
| Change in total fat mass | gram | Baseline, 6 months |
| Change in time in range (3.9-10.0 mmol/l) | percent (%) | Baseline, 6 months |
| Changes in time spent in hypoglycaemia (<3.9 mmol/l) | percent (%) | Baseline, 6 months |
| Change time spent in hyperglycaemia (e.g. >11.1 mmol/l) | percent (%) | Baseline, 6 months |
| Change in standard deviation of mean plasma glucose | mmol/l | Baseline, 6 months |
| Change in mathematical literacy | total score or percent (%) | Baseline, 6 months, 12 months |
| Change in carbohydrate estimation accuracy | total score or % | Baseline, 6 months, 12 months |
| Change in diet-related quality of life | total score or percent (%) | Baseline, 6 months, 12 months |
| Change in perceived competences in diabetes | total score or percent (%) | Baseline, 6 months, 12 months |
| Change in degree of autonomy-supportive dietitian | total score or percent (%) | Baseline, 6 months, 12 months |
| Change in total energy intake | kJ/day | Baseline, 6 months |
| Change in dietary intake of carbohydrates | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of total fat | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of saturated fatty acids (SFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of monounsaturated fatty acids (MUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of polyunsaturated fatty acids (PUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of protein | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of added sugar | gram/day , % of total energy or % | Baseline, 6 months |
| Change in intake of dietary fibre | gram/day or g/MJ | Baseline, 6 months |
| Baseline, 6 months |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2023 | Apr 25, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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