Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2018-03-01
2022-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Moderate carbohydrate diet
A healthy diet containing 30 E % carbohydrates
Moderate carbohydrate diet
30 E % carbohydrates included in the diet
Higher carbohydrate diet
A healthy diet containing 50 E % carbohydrates
Higher carbohydrate diet
50 E % carbohydrates included in the diet
Interventions
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Moderate carbohydrate diet
30 E % carbohydrates included in the diet
Higher carbohydrate diet
50 E % carbohydrates included in the diet
Eligibility Criteria
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Inclusion Criteria
* Adults 18 years or older
* Written Informed Consent
* HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Marcus Lind, PhD
Role: PRINCIPAL_INVESTIGATOR
NU Hospital Organization/University of Gothenburg
Locations
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NU Hospital Organization
Uddevalla, , Sweden
Countries
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References
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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.
Other Identifiers
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Carbohydrate study
Identifier Type: -
Identifier Source: org_study_id
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