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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate carbohydrate diet | Experimental | A healthy diet containing 30 E % carbohydrates |
|
| Higher carbohydrate diet | Experimental | A healthy diet containing 50 E % carbohydrates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate carbohydrate diet | Other | 30 E % carbohydrates included in the diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The difference in the proportion of time with high glucose levels |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HbA1c | The difference in HbA1c between week 4 and week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Lind, PhD | NU Hospital Organization/University of Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NU Hospital Organization | Uddevalla | 45180 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36992911 | Derived | Sterner Isaksson S, Olafsdottir AF, Lind M. Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes. Front Nutr. 2023 Mar 13;10:1114317. doi: 10.3389/fnut.2023.1114317. eCollection 2023. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Higher carbohydrate diet |
| Other |
50 E % carbohydrates included in the diet |
|
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
| Week 3-4, week 11-12 |
| 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 |
| Weight | The difference in weight between week 4 and week 12 | Week 4, week 12 |
| Total cholesterol | The difference in total cholesterol between week 4 and week 12 | Week 4, week 12 |
| LDL cholesterol | The difference in LDL cholesterol between week 4 and week 12 | Week 4, week 12 |
| HDL cholesterol | The difference in HDL cholesterol between week 4 and week 12 | Week 4, week 12 |
| Triglycerides | The difference in triglycerides between week 4 and week 12 | Week 4, week 12 |
| Total insulin dose | The difference in total insulin dose between week 1-4 and week 9-12 | Week 1-4, week 9-12 |
| Diabetes Treatment Satisfaction Questionnaire (DTSQc) score | The difference in DTSQc score at week 12 | Week 12 |
| Diabetes Treatment Satisfaction Questionnaire (DTSQs) score | The difference in DTSQs scores between week 4 and week 12 | Week 4, week 12 |
| Hypoglycemia confidence score | The difference in hypoglycaemia confidence scores between week 4 and week 12 | Week 4, week 12 |
| Week 4, week 12 |
| Apolipoproteins | The difference in apolipoproteins between week 4 and week 12 | Week 4, week 12 |
| 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 |
| Ketones | The difference in ketone levels between week 1-4 and week 9-12 | Week 1-4, week 9-12 |
| Ketoacidosis | Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12 | Week 1-4, week 9-12 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |