Clinical trial NCT04320433: Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry
Official title: Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Intolerance
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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)
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

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.

Primary outcomes:
measure: Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation
timeFrame: 7 days
Secondary outcomes:
measure: Inter-day reliability, 7 days apart, in post-prandial energy expenditure
timeFrame: 7 days
measure: Inter-day reliability, 7 days apart, in glucose levels
timeFrame: 7 days
Other outcomes:
measure: • Reliability of the O2 and CO2 metabolic cart sensors by pure gases infusions using a high-precision mass-flow controllers
timeFrame: Immediately after the participants' gas exhange measurements
Locations:
city: Granada
country: Spain
facility: Jonatan Ruiz Ruiz
Study officials:
affiliation: Universidad de Granada
name: juanma.alcantara@hotmail.com Ruiz Ruiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.