The Impact of Macronutrient Composition on Glucose Dynamics in Persons With Type 1 Diabetes - Trial NCT05268705
Access comprehensive clinical trial information for NCT05268705 through Pure Global AI's free database. This phase not specified trial is sponsored by Steno Diabetes Center Copenhagen and is currently Recruiting. The study focuses on type1diabetes. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Steno Diabetes Center Copenhagen
Timeline & Enrollment
N/A
Feb 03, 2022
Dec 31, 2023
Primary Outcome
The primary endpoint is the difference between study arms in difference from start to end plasma glucose concentration during 45 min fasted cycling (assessed by YSI (Yellow Spring Instruments 2900 STAT Plus)).
Summary
A randomized, open-label, three-arm crossover study will be conducted. The aim of the study
 is to determine the effect of different isocaloric diet macronutrient compositions
 (High-carbohydrate-Low-fat-Low-protein (HCLFLP), Low-carbohydrate-High-fat-Low-protein
 (LCHFLP), Low-carbohydrate-Low-fat-High-protein (LCLFHP)) on plasma glucose dynamics in
 everyday life and during fasted exercise in persons with type 1 diabetes. Our hypothesis is
 that a HCLFLP diet reduce the decrease in plasma glucose from start to end of fasted exercise
 compared with a LCHFLP diet. Secondary a LCHFLP compared with a LCLFHP diet does not reduces
 the decrease in plasma glucose from start to end of fasted exercise. The current study will
 contribute with new knowledge about the importance of the compositions of a low-carbohydrate
 diet on glucose dynamics and the influence on plasma glucose during and after cycling in
 fasted state.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05268705
Non-Device Trial