The GALAXY-1 Project
1 other identifier
interventional
8
1 country
1
Brief Summary
"The understanding of the two sugars, glucose and fructose, has been thoroughly investigated regarding their impact on human metabolism during exercise. The consumption of the sugar galactose is an intriguing alternative and can be beneficial, especially for individuals with type 1 Diabetes, as it reduces the need for insulin to maintain normal blood sugar levels. Additionally, galactose oxidation rates during exercise are only 50-60% compared to glucose, primarily due to liver storage and/or the requirement for conversion to glucose in the liver before oxidation. This delay in metabolism can prevent hyperglycemia before exercise and provide extended protection against episodes of hypoglycemia during and after exercise through a moderate and prolonged glycemic response. The purpose of this experiment is to investigate whether galactose is taken up by skeletal muscles and the heart in response to exercise or hyperinsulinemia. Using non-invasive 18F-FDGal PET, the investigators will examine this in a randomized controlled study design. The results could contribute to updating dietary recommendations, particularly for individuals with type 1 diabetes who struggle to maintain normal blood sugar levels during and after exercise."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2024
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedApril 23, 2024
August 1, 2023
9 months
August 3, 2023
April 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Galactose uptake in skeletal muscle
Skeletal muscle galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
Measurements will be made on each of the two study days
Secondary Outcomes (4)
Cardiac galactose uptake
Measurements will be made on each of the two study days
Hepatic galactose uptake
Measurements will be made on each of the two study days
Plasma glucose levels
Measurements will be made on a screening day and during each of the two study days
Skeletal muscle arterio-venous galactose balance
Measurements will be mader during each of the two study days
Study Arms (2)
Galactose
EXPERIMENTALThe participants will receive a galactose infusion
Saline
EXPERIMENTALThe participants will receive a saline infusion
Interventions
The participants will receive a galactose infusion (bolus: 6 mmol, infusion rate: 1 mmol/min)
Eligibility Criteria
You may qualify if:
- Age 50-75 years
- Male or post-menopausal female
- BMI 18.5-30 kg/m2
You may not qualify if:
- Clinically significant heart, lung, kidney, kidney, liver, endocrine or malignant disease based on information obtained during an initial screening visit as well as blood samples
- Blood donation within the last 3 months
- Smoking
- Alcohol- or substance abuse
- Participation in other clinical trials involving ionizing radiation within the last 6 months
- Claustrophobia
- Not being physically able to exercise one leg for one hour
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus N, Jutland, 8200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
February 12, 2024
Primary Completion
November 1, 2024
Study Completion
May 31, 2025
Last Updated
April 23, 2024
Record last verified: 2023-08