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

Primary Purpose

Glucose Intolerance

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oral glucose tolerance test
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glucose Intolerance

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jonatan Ruiz RuizRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2020
Last Updated
March 22, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04320433
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral glucose tolerance test
Intervention Description
Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).
Primary Outcome Measure Information:
Title
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation
Description
Reliability
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Inter-day reliability, 7 days apart, in post-prandial energy expenditure
Description
Reliability
Time Frame
7 days
Title
Inter-day reliability, 7 days apart, in glucose levels
Description
Reliability
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
• Reliability of the O2 and CO2 metabolic cart sensors by pure gases infusions using a high-precision mass-flow controllers
Description
o Inter-day reliability of gas composition (O2 and CO2) measurement by the Omnical® assessed by comparison with a high-precision mass-flow controllers.
Time Frame
Immediately after the participants' gas exhange measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonatan Ruiz Ruiz, Dr.
Phone
958242754
Ext
34
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Manuel Alcantara, PhD student
Email
juanma.alcantara@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
juanma.alcantara@hotmail.com Ruiz Ruiz, Dr.
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonatan Ruiz Ruiz
City
Granada
ZIP/Postal Code
18011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonatan Ruiz Ruiz, Dr
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name & Degree
Lucas Jurado Fasoli, PhD student
Email
juradofasoli@ugr.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36006468
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.
Results Reference
derived

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

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