- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846751
Exercise Type That Faster Reduces Postprandial Glycemia. (GLYEXER)
November 3, 2022 updated by: Ricardo Mora, University of Castilla-La Mancha
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toledo, Spain, 45071
- University of Castilla-La Mancha (Exercise Physiology Lab)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: AEROBIC EXERCISE
50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max
|
continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.
|
|
Placebo Comparator: PLACEBO REST
No exercise, resting during 50 min.
|
continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose concentration
Time Frame: 16 weeks
|
Incremental area under the curve during the 120 min of the oral glucose tolerance test
|
16 weeks
|
|
Blood insulin concentration
Time Frame: 16 weeks
|
Incremental area under the curve during the 120 min of the oral glucose tolerance test
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Carbohydrate oxidation
Time Frame: 16 weeks
|
Measured using indirect calorimetry
|
16 weeks
|
|
Turnover rate of endogenous and exogenous glucose
Time Frame: 16 weeks
|
Measured using isotopic tracers.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Anticipated)
August 30, 2023
Study Completion (Anticipated)
September 10, 2024
Study Registration Dates
First Submitted
April 11, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2020-116159RB-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be shared upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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