Glucose IntoleranceNCT04320433
Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry
A study testing Oral glucose tolerance test in people with Glucose Intolerance, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Juan Manuel Alcantara, PhD student contact
Spain1 site, 1 recruiting
- Recruiting
Jonatan Ruiz Ruiz
Granada, 18011
Jonatan Ruiz Ruiz, Dr, ruizj@ugr.es
Lucas Jurado Fasoli, PhD student, juradofasoli@ugr.es
About this study
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.
Read the 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.
- Conditions
- Glucose Intolerance
- Being tested
- Oral glucose tolerance test
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation
Reliability
Measured: 7 days
Secondary outcomes (2)
Inter-day reliability, 7 days apart, in post-prandial energy expenditure
Reliability
Measured: 7 days
Inter-day reliability, 7 days apart, in glucose levels
Reliability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
- Investigators
- juanma.alcantara@hotmail.com Ruiz Ruiz, Dr., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320433
- Sponsor's protocol ID
- 1102/CEIH/2020
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 Feb;62(1):351-361. doi: 10.1007/s00394-022-02986-w. Epub 2022 Aug 25.
PubMed 36006468
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-day Reliability of the Oral Glucose Tolerance Test Using Indirect Calorimetry
- ClinicalTrials.gov ID
- NCT04320433
- Acronym / sponsor ID
- 1102/CEIH/2020
- Conditions
- Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Oral glucose tolerance testParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testParticipants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France). | Diagnostic test | Experimental |
Primary outcome
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation
Time frame: 7 days
Reliability
2 secondary outcomes
Inter-day reliability, 7 days apart, in post-prandial energy expenditure
Time frame: 7 days
Inter-day reliability, 7 days apart, in glucose levels
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 36006468Alcantara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Manuel Alcantara, PhD student contact
juanma.alcantara@hotmail.com Ruiz Ruiz, Dr. principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose tolerance test in people with Glucose Intolerance, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonatan Ruiz Ruiz, Dr. (958242754 ext. 34, ruizj@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.