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Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03623139
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Bettina Ewers, Steno Diabetes Center

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Behavioral: Standard nutritional education Behavioral: Basic carbohydrate counting Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard nutritional education
Control group
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.
Other Name: Routine dietary care in type 2 diabetes

Experimental: BCC
Education and training i basic carbohydrate counting (BCC) plus standard nutritional education
Behavioral: Basic carbohydrate counting
The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
Other Name: Education in BCC in addition to standard dietary care




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623139


Contacts
Contact: Bettina Ewers, MSc +45 30912997 bettina.ewers@regionh.dk
Contact: Tina Vilsboell, DMSc tina.vilsboell.lauritsen.01@regionh.dk

Locations
Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, DK-2820
Contact: Bettina Ewers, MSc    +45 30912997    bettina.ewers@regionh.dk   
Principal Investigator: Bettina Ewers, MSc         
Sponsors and Collaborators
Steno Diabetes Center
University of Copenhagen
Investigators
Principal Investigator: Bettina Ewers, MSc Steno Diabetes Center Copenhagen

Responsible Party: Bettina Ewers, Head of nutrition, MSc, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT03623139     History of Changes
Other Study ID Numbers: H-18014918
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bettina Ewers, Steno Diabetes Center:
carbohydrates
basic carbohydrate counting
diet
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases