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Carbohydrate Content in the Diet in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03400618
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Moderate carbohydrate diet Other: Higher carbohydrate diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Moderate carbohydrate diet
A healthy diet containing 30 E % carbohydrates
Other: Moderate carbohydrate diet
30 E % carbohydrates included in the diet

Experimental: Higher carbohydrate diet
A healthy diet containing 50 E % carbohydrates
Other: Higher carbohydrate diet
50 E % carbohydrates included in the diet




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03400618


Contacts
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Contact: Sofia Isaksson, MSc 00460104350000 sofia.isaksson.2@gu.se
Contact: Marcus Lind, PhD 00460104350000 lind.marcus@telia.com

Locations
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Sweden
NU Hospital Organization Recruiting
Uddevalla, Sweden, 45180
Contact: Sofia Isaksson, MSc    00460104350000    sofia.isaksson.2@gu.se   
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Marcus Lind, PhD NU Hospital Organization/University of Gothenburg

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03400618     History of Changes
Other Study ID Numbers: Carbohydrate study
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
Carbohydrates
Diet
Diabetes Mellitus, Type 1
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases