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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557227
• Other study ID #: 93696
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: Rakel F Johansen, MD
• Phone: +45 40530612
• Email: rfjohansen[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia
• Hypoglycemia
• Type1diabetes

Intervention

Other:
• 1-hour cycling
60 % VO2 max

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood glucose variability	Change in blood glucose (mmol/l) over time	during and 2 hours after the bicycle test
Secondary	Glucose infusion	Volume of intravenous glucose needed to maintain glucose above 5 mmol/l	during and 2 hours after the bicycle test
Secondary	Respiratory exchange ratio	RER is measured to to assess carbohydrate and lipid metabolism	prior, during and 2 hours after the bicycle test
Secondary	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