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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Hypoglycemia; Type1diabetes
• Intervention / Treatment: Other: 1-hour cycling

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 Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rakel F Johansen, MD; Phone Number: +45 40530612; Email: rfjohansen@clin.au.dk
• Study Contact Backup: Name: Esben Sondergaard, MD; Phone Number: 28730943; Email: Esben.Sondergaard@clin.au.dk

Study Locations

• Denmark
  • Region Midt
    • Aarhus, Region Midt, Denmark, 8200
      • Recruiting
      • Steno Diabetes Center Aarhus
      • Contact: Rakel F Johansen, MD; Phone Number: +45 40530612

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: 93696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No