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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04846751
Other study ID # PID2020-116159RB-I00
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date September 10, 2024

Study information

Verified date November 2022
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT). 2. Exercise pedalling during 50 min in a hot environment (33ÂșC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT). 3. Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT). 4. No exercise, followed by an oral glucose tolerance test (OGTT).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 11
Est. completion date September 10, 2024
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
TYPE OF EXERCISE (OR REST)
continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.

Locations

Country Name City State
Spain University of Castilla-La Mancha (Exercise Physiology Lab) Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose concentration Incremental area under the curve during the 120 min of the oral glucose tolerance test 16 weeks
Primary Blood insulin concentration Incremental area under the curve during the 120 min of the oral glucose tolerance test 16 weeks
Secondary Carbohydrate oxidation Measured using indirect calorimetry 16 weeks
Secondary Turnover rate of endogenous and exogenous glucose Measured using isotopic tracers. 16 weeks
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