Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes
NCT ID: NCT02888691
Last Updated: 2023-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2016-08-31
2017-11-30
Brief Summary
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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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Low Carbohydrate Diet
\< 100 grams of carbohydrate per day
Low carbohydrate diet
High Carbohydrate Diet
\> 250 grams of carbohydrate per day
High carbohydrate diet
Interventions
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Low carbohydrate diet
High carbohydrate diet
Eligibility Criteria
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Inclusion Criteria
* Insulin pump use ≥1 year
* HbA1c ≥53 mmol/mol (7.0%)
* BMI 20-27 kg/m2
* Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
* Willingness to use continuous glucose monitoring consistently during the intervention periods
Exclusion Criteria
* Use of SGLT-2-inhibitors
* Use of corticosteroids during or within 30 days prior to the intervention periods
* Celiac disease
* Inflammatory bowel disease
* Macroalbuminuria
* Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
* Known or suspected alcohol or drug abuse
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Signe Schmidt
MD PhD
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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References
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Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.
Ji L, Li L, Ma J, Li X, Li D, Meng B, Lu W, Sun J, Liu Y, Takayanagi G, Wang Y. Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study. Endocrinol Diabetes Metab. 2021 Jan 20;4(2):e00222. doi: 10.1002/edm2.222. eCollection 2021 Apr.
Al-Sari N, Schmidt S, Suvitaival T, Kim M, Trost K, Ranjan AG, Christensen MB, Overgaard AJ, Pociot F, Norgaard K, Legido-Quigley C. Changes in the lipidome in type 1 diabetes following low carbohydrate diet: Post-hoc analysis of a randomized crossover trial. Endocrinol Diabetes Metab. 2021 Jan 4;4(2):e00213. doi: 10.1002/edm2.213. eCollection 2021 Apr.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HiLo12
Identifier Type: -
Identifier Source: org_study_id
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