NCT05268705

The Impact of Macronutrient Composition on Glucose Dynamics in Persons With Type 1 Diabetes

The Impact of Macronutrient Composition on Glucose Dynamics in Everyday Life and During Fasted Cycling in Persons With Type 1 Diabetes
Steno Diabetes Center Copenhagen·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
type1diabetes
Drug/Device/Intervention
7-day diet
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Steno Diabetes Center Copenhagen
Location
Herlev, Denmark
Timeline & enrollment
Phase
N/A
Start date
Feb 03, 2022
End date
Dec 31, 2023
Enrollment
12 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05268705
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.