The Impact of Macronutrient Composition on Glucose Dynamics in Everyday Life and During Fasted Cycling in Persons With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age ≥ 18 years

• Type 1 diabetes ≥ 5 years

• Insulin pump use ≥ 1 year

• Use of intermittently scanned continuous glucose monitoring (isCGM) or continuous glucose monitoring (CGM) ≥ 3 months

• HbA1c ≤ 69 mmol/mol (8.5%)

• Self-reported hypoglycemia awareness

• Exercising at least 30 minutes at moderate or vigorous intensity two times per week.

Locations
Other Locations
Denmark
Steno Diabetes Center Copenhagen
Recruiting
Herlev
Contact Information
Primary
Kasper B Kristensen, MD
kasper.birch.kristensen.01@regionh.dk
+45 20528949
Backup
Signe Schmidt, MD, PhD
signe.schmidt@regionh.dk
+45 51174785
Time Frame
Start Date: February 3, 2022
Estimated Completion Date: December 31, 2023
Participants
Target number of participants: 12
Treatments
Active Comparator: High-carbohydrate-low-fat-low-protein diet
Active Comparator: Low-carbohydrate-high-fat-low-protein diet
Active Comparator: Low-carbohydrate-low-fat-high-protein diet
Authors
Kirsten Nørgaard
Related Therapeutic Areas
Sponsors
Leads: Steno Diabetes Center Copenhagen
Collaborators: Swansea University

This content was sourced from clinicaltrials.gov

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