Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
On study days, a catheter is placed in two antecubital veins for regular blood sampling and for glucose infusion (if needed). The participant will rest in a bed, when not performing the 1-hour bicycle ergometer test.
Thirty minutes before the leg-cycle ergometer test, the participants consume a 300 ml beverage containing either: 1) dextrose (20 g), 2) galactose (20 g) 3) lactose (20 g) or 4) water (sweetened). At t=0, the ergometer test is started and continued for 1 hour (fixed intensity cycling at 60% of VO2-max). If blood glucose drops below 3.9 mmol/l, glucose infusion (5 % glucose) will be administered, and blood glucose is kept just above 5 mmol/l and infused volume is registered.
Blood samples are collected at t= -40, 0, 30, 60, 90, 120 for measurement of plasma lactate, non-esterified fatty acids (NEFA), plasma triglyceride and hormonal concentrations (epinephrine, norepinephrine, cortisol, and glucagon). Plasma blood glucose measurements are performed at t = -40 and every 10-15 minutes until the end of the study day.
Respiratory exchange ratio is measured by indirect calorimetry (collection of respiratory gasses VO2 and VCO2) pre-exercise, at the end of the exercise bout, and 30 minutes post-exercise. Protein oxidation rate is estimated from urinary urea excretion, and net lipid and glucose oxidation rates are calculated from indirect calorimetry measurements with correction for protein oxidation. Therefor a urine sample will also be collected at the end of the study day.
The bicycle ergometer test is discontinued after 1 hour of bicycling and the participant is observed until 2 hour post exercise where the study day is ended.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Galactose 30 g in 200 ml liquid |
Other: 1-hour cycling
60 % VO2 max
|
| Experimental: Lactose 30 g in 200 ml liquid |
Other: 1-hour cycling
60 % VO2 max
|
| Experimental: Dextrose 30 g in 200 ml liquid |
Other: 1-hour cycling
60 % VO2 max
|
| Experimental: Water 200 ml liquid sweetened |
Other: 1-hour cycling
60 % VO2 max
|
Outcome Measures
Primary Outcome Measures
- Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio. [during and 2 hours after the bicycle test]
time to blood glucose < 3.9 mmol/l
Secondary Outcome Measures
- Blood glucose variability [during and 2 hours after the bicycle test]
Change in blood glucose (mmol/l) over time
- Glucose infusion [during and 2 hours after the bicycle test]
Volume of intravenous glucose needed to maintain glucose above 5 mmol/l
- Respiratory exchange ratio [prior, during and 2 hours after the bicycle test]
RER is measured to to assess carbohydrate and lipid metabolism
- Time in Range [prior, during and 2 hours after the bicycle test]
Time spend with a blood glucose between 3,9 mmol/l and 10 mmol/l
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Steno Diabetes Center Aarhus | Aarhus | Region Midt | Denmark | 8200 |
Sponsors and Collaborators
- University of Aarhus
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 93696