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Completed

NCT Number: NCT03623139

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

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.

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Herlev, DK-2730, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Routine dietary care in type 2 diabetes

Basic carbohydrate counting

Behavioral

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

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline, 6 months

    mmol/mol

  2. Change in mean amplitude of glycaemic excursions (MAGE)

    Time frame: Baseline, 6 months

    mmol/l

Secondary outcomes

  1. Change in HbA1c

    Time frame: 12 months

    mmol/mol

  2. Change in body weight

    Time frame: Baseline, 6 months, 12 months

    kg

  3. Change in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  4. Change in high-density cholesterol (HDL-C)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  5. Change in total cholesterol (TC)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  6. Change in free fatty acids (FFA)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  7. Change in triglycerides (TG)

    Time frame: Baseline, 6 months, 12 months

    mmol/l

  8. Change in diastolic blood pressure

    Time frame: Baseline, 6 months, 12 months

    mm Hg

  9. Change in systolic blood pressure

    Time frame: Baseline, 6 months, 12 months

    mm Hg

  10. Change in waist circumference

    Time frame: Baseline, 6 months, 12 months

    cm

  11. Change in hip circumference

    Time frame: Baseline, 6 months, 12 months

    cm

  12. Change in total fat free mass

    Time frame: Baseline, 6 months

    gram

  13. Change in total fat mass

    Time frame: Baseline, 6 months

    gram

  14. Change in time in range (3.9-10.0 mmol/l)

    Time frame: Baseline, 6 months

    percent (%)

  15. Changes in time spent in hypoglycaemia (<3.9 mmol/l)

    Time frame: Baseline, 6 months

    percent (%)

  16. Change time spent in hyperglycaemia (e.g. >11.1 mmol/l)

    Time frame: Baseline, 6 months

    percent (%)

  17. Change in standard deviation of mean plasma glucose

    Time frame: Baseline, 6 months

    mmol/l

  18. Change in mathematical literacy

    Time frame: Baseline, 6 months, 12 months

    total score or percent (%)

  19. Change in carbohydrate estimation accuracy

    Time frame: Baseline, 6 months, 12 months

    total score or %

  20. Change in diet-related quality of life

    Time frame: Baseline, 6 months, 12 months

    total score or percent (%)

  21. Change in perceived competences in diabetes

    Time frame: Baseline, 6 months, 12 months

    total score or percent (%)

  22. Change in degree of autonomy-supportive dietitian

    Time frame: Baseline, 6 months, 12 months

    total score or percent (%)

  23. Change in total energy intake

    Time frame: Baseline, 6 months

    kJ/day

  24. Change in dietary intake of carbohydrates

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  25. Change in dietary intake of total fat

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  26. Change in dietary intake of saturated fatty acids (SFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  27. Change in dietary intake of monounsaturated fatty acids (MUFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  28. Change in dietary intake of polyunsaturated fatty acids (PUFA)

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  29. Change in dietary intake of protein

    Time frame: Baseline, 6 months

    gram/day or percent of total energy (E%)

  30. Change in dietary intake of added sugar

    Time frame: Baseline, 6 months

    gram/day , % of total energy or %

  31. Change in intake of dietary fibre

    Time frame: Baseline, 6 months

    gram/day or g/MJ

Other outcomes

  1. Change in physical activity level

    Time frame: Baseline, 6 months, 12 months

    total score or percent (%)

  2. Change in urinary biomarkers of carbohydrate intake

    Time frame: Baseline, 6 months

    percent (%)

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2018
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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