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

NCT05557227 | Completed DMC

• 1 other identifier: 93696
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type1diabetes; Hypoglycemia; Hyperglycemia

Outcome Measures

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 to blood glucose \< 3.9 mmol/l

  during and 2 hours after the bicycle test

Secondary Outcomes (4)

• Blood glucose variability

  during and 2 hours after the bicycle test

• Glucose infusion

  during and 2 hours after the bicycle test

• Respiratory exchange ratio

  prior, during and 2 hours after the bicycle test

• Time in Range

  prior, during and 2 hours after the bicycle test

Study Arms (4)

Galactose

EXPERIMENTAL

30 g in 200 ml liquid

Other: 1-hour cycling

Lactose

EXPERIMENTAL

30 g in 200 ml liquid

Other: 1-hour cycling

Dextrose

EXPERIMENTAL

30 g in 200 ml liquid

Other: 1-hour cycling

Water

EXPERIMENTAL

200 ml liquid sweetened

Other: 1-hour cycling

Interventions

1-hour cycling OTHER

60 % VO2 max

Dextrose; Galactose; Lactose; Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Region Midt, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 42264961 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: September 27, 2022
• Study Start: December 15, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 29, 2026

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)