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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galactose | Experimental | 30 g in 200 ml liquid |
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| Lactose | Experimental | 30 g in 200 ml liquid |
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| Dextrose | Experimental | 30 g in 200 ml liquid |
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| Water | Experimental | 200 ml liquid sweetened |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-hour cycling | Other | 60 % VO2 max |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio. | time to blood glucose < 3.9 mmol/l | during and 2 hours after the bicycle test |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose variability | Change in blood glucose (mmol/l) over time | during and 2 hours after the bicycle test |
| Glucose infusion | Volume of intravenous glucose needed to maintain glucose above 5 mmol/l |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | Region Midt | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42264961 | Derived | Schmidt KR, Johansen RF, Riis SB, Larsen MS, Stovring H, Wallis GA, Rowlands D, Gormsen LC, Sondergaard E. Pre-Exercise Galactose or Lactose Reduces Glycaemic Excursions During Exercise in Adults With Type 1 Diabetes: A Randomised, Double-Blind, Crossover Trial. Diabetes Obes Metab. 2026 Jun 9. doi: 10.1111/dom.70958. Online ahead of print. |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The study is a single-blinded, randomized crossover study, consisting of 4 study days of 1-hour fixed intensity cycling, after consumption of either galactose, lactose, glucose or water.
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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.
| during and 2 hours after the bicycle test |
| Respiratory exchange ratio | RER is measured to to assess carbohydrate and lipid metabolism | prior, during and 2 hours after the bicycle test |
| Time in Range | Time spend with a blood glucose between 3,9 mmol/l and 10 mmol/l | prior, during and 2 hours after the bicycle test |