Clinical trial NCT03400618: Carbohydrate Content in the Diet in Type 1 Diabetes
Official title: The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Carbohydrates
Diet
Diabetes Mellitus, Type 1
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-01-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The difference in mean glucose level
timeFrame: Week 3-4, week 11-12
Secondary outcomes:
measure: The difference in standard deviation of glucose levels
timeFrame: Week 3-4, week 11-12
measure: The difference in the proportion of time with high glucose levels
timeFrame: Week 3-4, week 11-12
measure: The difference in the proportion of time with euglycaemic levels
timeFrame: Week 3-4, week 11-12
measure: Weight
timeFrame: Week 4, week 12
measure: Total cholesterol
timeFrame: Week 4, week 12
measure: LDL cholesterol
timeFrame: Week 4, week 12
measure: HDL cholesterol
timeFrame: Week 4, week 12
measure: Triglycerides
timeFrame: Week 4, week 12
measure: Total insulin dose
timeFrame: Week 1-4, week 9-12
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
timeFrame: Week 12
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
timeFrame: Week 4, week 12
measure: Hypoglycemia confidence score
timeFrame: Week 4, week 12
Other outcomes:
measure: The difference in Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: Week 3-4, week 11-12
measure: HbA1c
timeFrame: Week 4, week 12
measure: Apolipoproteins
timeFrame: Week 4, week 12
measure: The difference in the proportion of time with low glucose levels
timeFrame: Week 3-4, week 11-12
measure: Ketones
timeFrame: Week 1-4, week 9-12
measure: Ketoacidosis
timeFrame: Week 1-4, week 9-12
Locations:
city: Uddevalla
country: Sweden
facility: NU Hospital Organization
Study officials:
affiliation: NU Hospital Organization/University of Gothenburg
name: Marcus Lind, PhD
role: PRINCIPAL_INVESTIGATOR
References: