Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry

NCT ID: NCT04320433

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main aim of this study is to determine the inter-day reliability, by using indirect calorimetry, of the post-prandial macronutrient oxidation and energy expenditure after consuming oral glucose load solution.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The maintenance of blood glucose concentrations and the oxidation of carbohydrate after consuming carbohydrate is related with a low risk of mortality and morbidity from cardiometabolic diseases. The oral glucose tolerance test is a diagnostic test widely used in the clinical field. However, its inter-day reliability has not been deeply studied. Therefore, it is of clinical interest to study the inter-day reliability of the diagnostic test oral glucose tolerance test using indirect calorimetry and monitoring the response of the glucose levels.

20 young adults will undergo two trials visit with 7 days of separation between conditions. Each evaluation day will conform to the following tests:

1. Basal metabolic rate assessment through indirect calorimetry.
2. Basal heart rate variability through heart rate monitor.
3. Intake of the corresponding glucose load solution.
4. Postprandial nutrient oxidation and energy expenditure assessment through indirect calorimetry
5. Glucose monitoring through Glucose meter.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glucose Intolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Participants will undergo two trials visit (with a week of separation). During the visits they will ingest an oral glucose load solution (oral glucose tolerance test) and gas exchange will be measured over the following 3-hours. The glucose levels will be monitored through a Glucose meter in different time frames.

Group Type EXPERIMENTAL

Oral glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral glucose tolerance test

Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female
* Ages 18-30 years
* BMI: 18-27.5 kg/m2
* Stable weight over the last 3 months (body weight changes\<35kg)

Exclusion Criteria

* History of cardiovascular disease
* Diabetes or hypertension
* Pregnant, planning to become pregnant, or breastfeeding
* Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
* Claustrophobia
* Needle phobia
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonatan Ruiz Ruiz

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

[email protected] Ruiz Ruiz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jonatan Ruiz Ruiz

Granada, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jonatan Ruiz Ruiz, Dr.

Role: CONTACT

958242754 ext. 34

Juan Manuel Alcantara, PhD student

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jonatan Ruiz Ruiz, Dr

Role: primary

Lucas Jurado Fasoli, PhD student

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Alcantara JMA, Sanchez-Delgado G, Jurado-Fasoli L, Galgani JE, Labayen I, Ruiz JR. Reproducibility of the energy metabolism response to an oral glucose tolerance test: influence of a postcalorimetric correction procedure. Eur J Nutr. 2023 Feb;62(1):351-361. doi: 10.1007/s00394-022-02986-w. Epub 2022 Aug 25.

Reference Type DERIVED
PMID: 36006468 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1102/CEIH/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enteral Nutrition and Glucose Homeostasis
NCT03012867 COMPLETED PHASE4
HIT on Hypoglycaemic Risk in T1D
NCT05044442 COMPLETED NA