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Completed

NCT Number: NCT05557227

Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus

Aarhus, Region Midt, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1-hour cycling

Other

60 % VO2 max

Primary outcomes

  1. Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio.

    Time frame: during and 2 hours after the bicycle test

    time to blood glucose < 3.9 mmol/l

Secondary outcomes

  1. Blood glucose variability

    Time frame: during and 2 hours after the bicycle test

    Change in blood glucose (mmol/l) over time

  2. Glucose infusion

    Time frame: during and 2 hours after the bicycle test

    Volume of intravenous glucose needed to maintain glucose above 5 mmol/l

  3. Respiratory exchange ratio

    Time frame: prior, during and 2 hours after the bicycle test

    RER is measured to to assess carbohydrate and lipid metabolism

  4. Time in Range

    Time frame: prior, during and 2 hours after the bicycle test

    Time spend with a blood glucose between 3,9 mmol/l and 10 mmol/l

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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