NCT04846751

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

April 11, 2021

Last Update Submit

November 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood glucose concentration

    Incremental area under the curve during the 120 min of the oral glucose tolerance test

    16 weeks

  • Blood insulin concentration

    Incremental area under the curve during the 120 min of the oral glucose tolerance test

    16 weeks

Secondary Outcomes (2)

  • Carbohydrate oxidation

    16 weeks

  • Turnover rate of endogenous and exogenous glucose

    16 weeks

Study Arms (2)

AEROBIC EXERCISE

ACTIVE COMPARATOR

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

Behavioral: TYPE OF EXERCISE (OR REST)

PLACEBO REST

PLACEBO COMPARATOR

No exercise, resting during 50 min.

Behavioral: TYPE OF EXERCISE (OR REST)

Interventions

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

AEROBIC EXERCISEPLACEBO REST

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers
  • Pregnancy
  • Any non-controlled medical condition which could influence results or could be worsened by exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Hyperinsulinemic hypoglycemia, familial, 7

Study Officials

  • Ricardo Mora-Rodriguez, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Exercise Lab at Toledo

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 15, 2021

Study Start

November 1, 2021

Primary Completion

August 30, 2023

Study Completion

September 10, 2024

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Data will be shared upon reasonable request.

Locations