University of Aarhus
Rakel Johansen
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.
Type1diabetes
Hypoglycemia
Hyperglycemia
1-hour cycling
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 14 participants |
Masking: | Single |
Masking Description: | The participants will receive either dextrose, water, lactose, galactose in a randomized order (computer generated block randomization) prior to a one-hour exercise bout. Participants, but not investigators, are masked to nutrition allocation. |
Primary Purpose: | Prevention |
Official Title: | Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes |
Actual Study Start Date : | December 15, 2022 |
Estimated Primary Completion Date : | January 1, 2024 |
Estimated Study Completion Date : | June 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Galactose 30 g in 200 ml liquid |
Other: 1-hour cycling |
Experimental: Lactose 30 g in 200 ml liquid |
Other: 1-hour cycling |
Experimental: Dextrose 30 g in 200 ml liquid |
Other: 1-hour cycling |
Experimental: Water 200 ml liquid sweetened |
Other: 1-hour cycling |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Steno Diabetes Center Aarhus
Aarhus, Region Midt, Denmark, 8200