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

Primary Purpose

Type1diabetes, Hypoglycemia, Hyperglycemia

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
1-hour cycling
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type1diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center AarhusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Galactose

Lactose

Dextrose

Water

Arm Description

30 g in 200 ml liquid

30 g in 200 ml liquid

30 g in 200 ml liquid

200 ml liquid sweetened

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood glucose variability
Change in blood glucose (mmol/l) over time
Glucose infusion
Volume of intravenous glucose needed to maintain glucose above 5 mmol/l
Respiratory exchange ratio
RER is measured to to assess carbohydrate and lipid metabolism
Time in Range
Time spend with a blood glucose between 3,9 mmol/l and 10 mmol/l

Full Information

First Posted
August 15, 2022
Last Updated
December 15, 2022
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05557227
Brief Title
Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes
Official Title
Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Hypoglycemia, Hyperglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Galactose
Arm Type
Experimental
Arm Description
30 g in 200 ml liquid
Arm Title
Lactose
Arm Type
Experimental
Arm Description
30 g in 200 ml liquid
Arm Title
Dextrose
Arm Type
Experimental
Arm Description
30 g in 200 ml liquid
Arm Title
Water
Arm Type
Experimental
Arm Description
200 ml liquid sweetened
Intervention Type
Other
Intervention Name(s)
1-hour cycling
Intervention Description
60 % VO2 max
Primary Outcome Measure Information:
Title
Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio.
Description
time to blood glucose < 3.9 mmol/l
Time Frame
during and 2 hours after the bicycle test
Secondary Outcome Measure Information:
Title
Blood glucose variability
Description
Change in blood glucose (mmol/l) over time
Time Frame
during and 2 hours after the bicycle test
Title
Glucose infusion
Description
Volume of intravenous glucose needed to maintain glucose above 5 mmol/l
Time Frame
during and 2 hours after the bicycle test
Title
Respiratory exchange ratio
Description
RER is measured to to assess carbohydrate and lipid metabolism
Time Frame
prior, during and 2 hours after the bicycle test
Title
Time in Range
Description
Time spend with a blood glucose between 3,9 mmol/l and 10 mmol/l
Time Frame
prior, during and 2 hours after the bicycle test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rakel F Johansen, MD
Phone
+45 40530612
Email
rfjohansen@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Esben Sondergaard, MD
Phone
28730943
Email
Esben.Sondergaard@clin.au.dk
Facility Information:
Facility Name
Steno Diabetes Center Aarhus
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakel F Johansen, MD
Phone
+45 40530612

12. IPD Sharing Statement

Plan to Share IPD
No

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

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