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

NCT ID: NCT05557227

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type1diabetes Hypoglycemia Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Galactose

30 g in 200 ml liquid

Group Type EXPERIMENTAL

1-hour cycling

Intervention Type OTHER

60 % VO2 max

Lactose

30 g in 200 ml liquid

Group Type EXPERIMENTAL

1-hour cycling

Intervention Type OTHER

60 % VO2 max

Dextrose

30 g in 200 ml liquid

Group Type EXPERIMENTAL

1-hour cycling

Intervention Type OTHER

60 % VO2 max

Water

200 ml liquid sweetened

Group Type EXPERIMENTAL

1-hour cycling

Intervention Type OTHER

60 % VO2 max

Interventions

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1-hour cycling

60 % VO2 max

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Rakel Johansen

Principal investigator, MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Steno Diabetes Center Aarhus

Aarhus, Region Midt, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Rakel F Johansen, MD

Role: CONTACT

Phone: +45 40530612

Email: [email protected]

Esben Sondergaard, MD

Role: CONTACT

Phone: 28730943

Email: [email protected]

Facility Contacts

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Rakel F Johansen, MD

Role: primary

Other Identifiers

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93696

Identifier Type: -

Identifier Source: org_study_id