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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320433
• Other study ID #: 1102/CEIH/2020
• Status: Recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: Universidad de Granada
• Contact: Jonatan Ruiz Ruiz, Dr.
• Phone: 958242754
• Email: ruizj[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

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).

Locations

Country	Name	City	State
Spain	Jonatan Ruiz Ruiz	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• 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
Primary	Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation	Reliability	7 days
Secondary	Inter-day reliability, 7 days apart, in post-prandial energy expenditure	Reliability	7 days
Secondary	Inter-day reliability, 7 days apart, in glucose levels	Reliability	7 days