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

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.

Study Overview

• Status: Unknown
• Conditions: Glucose Intolerance
• Intervention / Treatment: Diagnostic test: Oral glucose tolerance test

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18011
    • Recruiting
    • Jonatan Ruiz Ruiz
    • Contact: Jonatan Ruiz Ruiz, Dr; Email: ruizj@ugr.es
    • Contact: Lucas Jurado Fasoli, PhD student; Email: juradofasoli@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Oral glucose tolerance test; Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation	Reliability	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-day reliability, 7 days apart, in post-prandial energy expenditure	Reliability	7 days
Inter-day reliability, 7 days apart, in glucose levels	Reliability	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Reliability of the O2 and CO2 metabolic cart sensors by pure gases infusions using a high-precision mass-flow controllers	o Inter-day reliability of gas composition (O2 and CO2) measurement by the Omnical® assessed by comparison with a high-precision mass-flow controllers.	Immediately after the participants' gas exhange measurements

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: juanma.alcantara@hotmail.com Ruiz Ruiz, Dr., Universidad de Granada

Publications and helpful links

General Publications

• 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. 2022 Aug 25. doi: 10.1007/s00394-022-02986-w. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: 1102/CEIH/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No