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NCT Number: NCT03400618

Carbohydrate Content in the Diet in Type 1 Diabetes

The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).

The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NU Hospital Organization

Uddevalla, 45180, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Adults 18 years or older
  • Written Informed Consent
  • HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)

Exclusion criteria

  • Pregnancy or planned pregnancy for the study duration
  • Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
  • Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
  • Diabetes duration < 1 year
  • Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
  • Other investigator-determined criteria unsuitable for patient participation

Treatment and study plan

moderate carbohydrate diet

Other

30 E % carbohydrates included in the diet

Higher carbohydrate diet

Other

50 E % carbohydrates included in the diet

Primary outcomes

  1. The difference in mean glucose level

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

Secondary outcomes

  1. The difference in standard deviation of glucose levels

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

  2. The difference in the proportion of time with high glucose levels

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

  3. The difference in the proportion of time with euglycaemic levels

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

  4. Weight

    Time frame: Week 4, week 12

    The difference in weight between week 4 and week 12

  5. Total cholesterol

    Time frame: Week 4, week 12

    The difference in total cholesterol between week 4 and week 12

  6. LDL cholesterol

    Time frame: Week 4, week 12

    The difference in LDL cholesterol between week 4 and week 12

  7. HDL cholesterol

    Time frame: Week 4, week 12

    The difference in HDL cholesterol between week 4 and week 12

  8. Triglycerides

    Time frame: Week 4, week 12

    The difference in triglycerides between week 4 and week 12

  9. Total insulin dose

    Time frame: Week 1-4, week 9-12

    The difference in total insulin dose between week 1-4 and week 9-12

  10. Diabetes Treatment Satisfaction Questionnaire (DTSQc) score

    Time frame: Week 12

    The difference in DTSQc score at week 12

  11. Diabetes Treatment Satisfaction Questionnaire (DTSQs) score

    Time frame: Week 4, week 12

    The difference in DTSQs scores between week 4 and week 12

  12. Hypoglycemia confidence score

    Time frame: Week 4, week 12

    The difference in hypoglycaemia confidence scores between week 4 and week 12

Other outcomes

  1. The difference in Mean Amplitude of Glycemic Excursions (MAGE)

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

  2. HbA1c

    Time frame: Week 4, week 12

    The difference in HbA1c between week 4 and week 12

  3. Apolipoproteins

    Time frame: Week 4, week 12

    The difference in apolipoproteins between week 4 and week 12

  4. The difference in the proportion of time with low glucose levels

    Time frame: Week 3-4, week 11-12

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

  5. Ketones

    Time frame: Week 1-4, week 9-12

    The difference in ketone levels between week 1-4 and week 9-12

  6. Ketoacidosis

    Time frame: Week 1-4, week 9-12

    Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2018
Registry last updated
Apr 26, 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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