MedTrace Logo

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

NCT05268705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-09

No results posted yet for this study

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.

Conditions

  • type1diabetes

Interventions

OTHER

7-day diet

The participants must follow a 7-day high-carbohydrate-low-fat-low-protein diet before the inclinic study visit at day 8. The in-clinic study visits are identical for all the three study arms.

OTHER

7-day diet

The participants must follow a low-carbohydrate-high-fat-low-protein diet before the inclinic study visit at day 8. The in-clinic study visits are identical for all the three study arms.

OTHER

7-day diet

The participants must follow a low-carbohydrate-low-fat-high-protein diet before the inclinic study visit at day 8. The in-clinic study visits are identical for all the three study arms.

Sponsors & Collaborators

  • Swansea University

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Kirsten Nørgaard, Professor · Steno Diabetes Center Copenhagen, Clinical Reseach, Diabetes Technology Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2022-11-08
Completion
2022-11-08

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268705 on ClinicalTrials.gov