Carbohydrate Content in the Diet in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400618
• Other study ID #: Carbohydrate study
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• Moderate carbohydrate diet
30 E % carbohydrates included in the diet
• Higher carbohydrate diet
50 E % carbohydrates included in the diet

Locations

Country	Name	City	State
Sweden	NU Hospital Organization	Uddevalla

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The difference in Mean Amplitude of Glycemic Excursions (MAGE)	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Other	HbA1c	The difference in HbA1c between week 4 and week 12	Week 4, week 12
Other	Apolipoproteins	The difference in apolipoproteins between week 4 and week 12	Week 4, week 12
Other	The difference in the proportion of time with low glucose levels	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Other	Ketones	The difference in ketone levels between week 1-4 and week 9-12	Week 1-4, week 9-12
Other	Ketoacidosis	Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12	Week 1-4, week 9-12
Primary	The difference in mean glucose level	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Secondary	The difference in standard deviation of glucose levels	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Secondary	The difference in the proportion of time with high glucose levels	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Secondary	The difference in the proportion of time with euglycaemic levels	Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12	Week 3-4, week 11-12
Secondary	Weight	The difference in weight between week 4 and week 12	Week 4, week 12
Secondary	Total cholesterol	The difference in total cholesterol between week 4 and week 12	Week 4, week 12
Secondary	LDL cholesterol	The difference in LDL cholesterol between week 4 and week 12	Week 4, week 12
Secondary	HDL cholesterol	The difference in HDL cholesterol between week 4 and week 12	Week 4, week 12
Secondary	Triglycerides	The difference in triglycerides between week 4 and week 12	Week 4, week 12
Secondary	Total insulin dose	The difference in total insulin dose between week 1-4 and week 9-12	Week 1-4, week 9-12
Secondary	Diabetes Treatment Satisfaction Questionnaire (DTSQc) score	The difference in DTSQc score at week 12	Week 12
Secondary	Diabetes Treatment Satisfaction Questionnaire (DTSQs) score	The difference in DTSQs scores between week 4 and week 12	Week 4, week 12
Secondary	Hypoglycemia confidence score	The difference in hypoglycaemia confidence scores between week 4 and week 12	Week 4, week 12