GLYEXER: Exercise Type That Faster Reduces Postprandial Glycemia.

Sponsor

University of Castilla-La Mancha (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04846751

Collaborator

(none)

Enrollment

Location

Arms

22.3

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose, High Blood Exercise-Induced Hyperinsulinism	Behavioral: TYPE OF EXERCISE (OR REST)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Exercise Type That Faster Reduces Postprandial Glycemia.

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Sep 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AEROBIC EXERCISE 50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max	Behavioral: TYPE OF EXERCISE (OR REST) 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.	Behavioral: TYPE OF EXERCISE (OR REST) continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.

Arm

Intervention/Treatment

Active Comparator: AEROBIC EXERCISE

50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max

Behavioral: TYPE OF EXERCISE (OR REST)

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.

Behavioral: TYPE OF EXERCISE (OR REST)

continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.

Outcome Measures

Primary Outcome Measures

Blood glucose concentration [16 weeks]
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Blood insulin concentration [16 weeks]
Incremental area under the curve during the 120 min of the oral glucose tolerance test

Secondary Outcome Measures

Carbohydrate oxidation [16 weeks]
Measured using indirect calorimetry
Turnover rate of endogenous and exogenous glucose [16 weeks]
Measured using isotopic tracers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Castilla-La Mancha (Exercise Physiology Lab)	Toledo		Spain	45071

Sponsors and Collaborators

University of Castilla-La Mancha

Investigators

Principal Investigator: Ricardo Mora-Rodriguez, PhD, University of Castilla-La Mancha

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo Mora, Director of the Exercise Lab at Toledo, University of Castilla-La Mancha

ClinicalTrials.gov Identifier:

NCT04846751

Other Study ID Numbers:

PID2020-116159RB-I00

First Posted:

Apr 15, 2021

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperinsulinism

Study Results

No Results Posted as of Sep 20, 2021