Exercise Type That Faster Reduces Postprandial Glycemia. (GLYEXER)
Primary Purpose
Glucose, High Blood, Exercise-Induced Hyperinsulinism
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TYPE OF EXERCISE (OR REST)
Sponsored by
About this trial
This is an interventional prevention trial for Glucose, High Blood
Eligibility Criteria
Inclusion Criteria:
- Participant must be capable and willing to provide consent, understand, instructions and protocols.
- Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.
Exclusion Criteria:
- Smokers
- Pregnancy
- Any non-controlled medical condition which could influence results or could be worsened by exercise
Sites / Locations
- University of Castilla-La Mancha (Exercise Physiology Lab)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
AEROBIC EXERCISE
PLACEBO REST
Arm Description
50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max
No exercise, resting during 50 min.
Outcomes
Primary Outcome Measures
Blood glucose concentration
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Blood insulin concentration
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Secondary Outcome Measures
Carbohydrate oxidation
Measured using indirect calorimetry
Turnover rate of endogenous and exogenous glucose
Measured using isotopic tracers.
Full Information
NCT ID
NCT04846751
First Posted
April 11, 2021
Last Updated
November 3, 2022
Sponsor
University of Castilla-La Mancha
1. Study Identification
Unique Protocol Identification Number
NCT04846751
Brief Title
Exercise Type That Faster Reduces Postprandial Glycemia.
Acronym
GLYEXER
Official Title
Exercise Type That Faster Reduces Postprandial Glycemia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Castilla-La Mancha
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
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.
Detailed Description
Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.
Participants will undergo in a cross-over randomized fashion the following trials:
Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).
No exercise, followed by an oral glucose tolerance test (OGTT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose, High Blood, Exercise-Induced Hyperinsulinism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AEROBIC EXERCISE
Arm Type
Active Comparator
Arm Description
50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max
Arm Title
PLACEBO REST
Arm Type
Placebo Comparator
Arm Description
No exercise, resting during 50 min.
Intervention Type
Behavioral
Intervention Name(s)
TYPE OF EXERCISE (OR REST)
Intervention Description
continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.
Primary Outcome Measure Information:
Title
Blood glucose concentration
Description
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Time Frame
16 weeks
Title
Blood insulin concentration
Description
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Carbohydrate oxidation
Description
Measured using indirect calorimetry
Time Frame
16 weeks
Title
Turnover rate of endogenous and exogenous glucose
Description
Measured using isotopic tracers.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant must be capable and willing to provide consent, understand, instructions and protocols.
Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.
Exclusion Criteria:
Smokers
Pregnancy
Any non-controlled medical condition which could influence results or could be worsened by exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Mora-Rodriguez, PhD
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Castilla-La Mancha (Exercise Physiology Lab)
City
Toledo
ZIP/Postal Code
45071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared upon reasonable request.
Learn more about this trial
Exercise Type That Faster Reduces Postprandial Glycemia.
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