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

Not Applicable

• Conditions: Glucose Intolerance
• Interventions: Diagnostic Test: Oral glucose tolerance test

• Registration Number: NCT04320433
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-22
• Last Update Submitted: 2020-03-22
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25
• Study Start: 2020-04
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Oral glucose tolerance test	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.

Primary Outcome Measures

Name	Time	Method
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation	7 days	Reliability

Secondary Outcome Measures

Name	Time	Method
Inter-day reliability, 7 days apart, in post-prandial energy expenditure	7 days	Reliability
Inter-day reliability, 7 days apart, in glucose levels	7 days	Reliability

Trial Locations

Locations (1)

Jonatan Ruiz Ruiz; 🇪🇸 Granada, Spain