Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes (NCT05557227) | Clinical Trial Compass
CompletedNot Applicable
Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes
Denmark14 participantsStarted 2022-12-15
Plain-language summary
In this study, 14 subjects with type 1 diabetes are studied in a randomized crossover study in which the subjects cycle at a fixed intensity at 60% of their maximum oxygen capacity (VO2 max) for 1 hour. Thirty minutes before each cycling test, participants consume a 200 ml beverage, consisting of either: 1) dextrose (20 g), 2) galactose (20 g), 3) lactose (20 g) or 4) water (sweetened). If blood sugar drops below 3.9 mmol/l, glucose infusion is given and blood sugar is kept just above 5 mmol/L.
The trial days take place at least 4 days apart.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* type 1 diabetes for at least 2 years
* age between 18 and 65 years
* HbA1c less than 70 mmol/mol
* Physically active (at least 150 minutes of moderate-to-vigorous intensity activity weekly)
* Insulin pen and pump treatment
* Men and women are eligible, but women will have to perform study days in the mid-cycle phase of the menstrual cycle.
Exclusion Criteria:
* \- Diabetic nephropathy, neuropathy, and proliferative retinopathy
* Hypoglycemia unawareness
* Lactose intolerance
* Heart disease and other conditions which may be negatively affected by the VO2 max test and 1-hour cycling on study days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio.
Timeframe: during and 2 hours after the bicycle test