Non-Diabetic Disorder of Endocrine PancreasONTIME-MTNCT03036592
MTNR1B SNP*Food Timing Interaction on Glucose Control
A study testing Early OGTT and Late OGTT in people with Non-Diabetic Disorder of Endocrine Pancreas, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B) single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the deleterious effect in a vulnerable population with regular exposure to concurrent high melatonin and food intake as late night eaters (those… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Diabetic Disorder of Endocrine Pancreas
- What is being tested?
- Early OGTT and Late OGTT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 889 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index: > 18.5 o < 40 kg/m2
- Age: between 18 and 65 year of age
- European ancestry
- Day workers
Who cannot join
- Receiving treatment with thermogenic, lipogenic, or drugs
- Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
- Bulimia diagnosis, prone to binge eating
- Undergoing treatment with Type 2 diabetes mellitus (high blood sugar) medications such as Metformin or other non-Metformin oral anti-diabetic drugs such as sulfonylureas, meglitinides, or glitazones
- Undergoing treatment with Corticosteroids/steroids, Growth hormone, Anticoagulant medicines, or blood thinners, Beta blockers for hypertension, Medications for sleep, Fluvoxamine, Opioids or Amphetamines, Tranquilizers, nonsteroidal anti-inflammatory drugs.
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B) single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the deleterious effect in a vulnerable population with regular exposure to concurrent high melatonin and food intake as late night eaters (those having dinner within 2.5 h before their usual bed time). With the results from this study, we expect to advance our understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.
Read the detailed description
Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.
The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two glucose oral tolerance test (OGTT) conditions: a) delayed OGTT or Late Eating (LE): starting1 hour before their usual bed time, b) advanced OGTT or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.
These findings could support a clinical application for the screening of this SNP and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.
These goals will be achieved through a specific approach:
- Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance (n=1000).
- Being tested
- Early OGTT, Late OGTT
- Keywords
- Glucose tolerance test, MTNR1B, nutrigenomics, food timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early OGTTBehavioural
Oral glucose tolerance test using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)
Late OGTTBehavioural
Oral glucose tolerance test using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime)
| Study group | Role | What they receive |
|---|---|---|
| Early OGTT, then late OGTT in MTNR1B CC | Experimental | Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
| Early OGTT, then late OGTT in MTNR1B CG | Experimental | Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
| Early OGTT, then late OGTT in MTNR1B GG | Experimental | Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
| Late OGTT, then Early OGTT in MTNR1B CC | Experimental | Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
| Late OGTT, then Early OGTT in MTNR1B CG | Experimental | Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
| Late OGTT, then Early OGTT in MTNR1B GG | Experimental | Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions Receives: Behavioral: Early OGTT; Behavioral: Late OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) Glucose
Glucose levels are measured along 120 minutes corresponding to at early and late condition in each visit. The Area Under the Curve was calculated as the sum of the area of several trapezoids. This trapezoids was obtained at times 0-30 min, 30-60 min, 60-90 min, 90-120 min. The values are the difference between the late and the early condition.
Measured: Along 120 minutes in visits 1 and 2
Disposition Index (DI)
Disposition Index (DI) is the product of insulin sensitivity times by the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. This index was determined by this formula:
DI= CIR × ISI, where CIR is the measure Corrected Insulin Response, and ISI is Insulin Sensitivity Index. The values are the difference between the late and the early condition.
Higher DI indicates an increased beta cell function and increased ability of the body to dispose of a glucose load.
Measured: Along 120 minutes in visits 1 and 2
Secondary outcomes (6)
Corrected Insulin Response (CIR)
The measure of Corrected Insulin Response (CIR) uses the insulin and glucose levels at minute 30, integrating these values in the formula:
CIR= l30/(G30 × (G30 - 70)).The values are the difference between the late and the early conditions.
CIR is an index that assesses the insulin secretion capacity of B cells. A low CIR implies hyposecretion in response to glucose levels.
Measured: At minute 30 during the visit 1 and 2.
Insulin Sensitivity Index (ISI)
Insulin Sensitivity Index is a measurement which integrates fasting glucose and insulin concentrations (0 min) and the mean of the glucose and insulin levels from 0 to 120 minutes (0, 30, 60, 90 and 120 min), from an OGTT, to measure insulin sensitivity. This formula allows its use in clinical settings as well as in large epidemiological studies. The values are the difference between the late and the early condition.
Elevated ISI values typically indicate a favorable outcome. This index reflects the body's responsiveness to insulin, a hormone crucial for regulating blood sugar levels. Higher sensitivity to insulin suggests that cells efficiently utilize insulin's signals, promoting better blood sugar management. Lower ISI may lead to challenges in maintaining stable blood glucose levels and is often associated with conditions such as type 2 diabetes and metabolic syndrome.
Measured: Along 120min in visits 1 and 2
Fasting Glucose
Fasting glucose (or basal glucose) is a simple measurement of glucose concentrations at minute 0 to see how glucose levels rise immediately after an OGTT. The values are the difference between the late and the early condition.
Measured: At minute 0 in visit 1 and 2.
Fasting Insulin
Fasting insulin (or basal insulin) is a simple measurement of insulin concentrations at minute 0 to see how insulin levels rise immediately after an OGTT.The values are the difference between the late and the early condition.
Measured: At minute 0 in visit 1 and 2
Serum Melatonin
Measurement of serum melatonin is made at time 0 and at time 120 in both the early and late conditions of everyone.
Measured: At baseline and 120 minutes in visit 1 and 2
Dim Light Melatonin Onset (DLMO) at Early Condition Only
This measurement shows the decimal time of the onset of melatonin in dim light conditions. In the case of DLMO, we only performed this measure at the early condition in order to get the analysis of melatonin during 5 hours (4 hours before the habitual bedtime and 1 hour later), as it is described in literature (DOI: 10.1002/oby.23749).
Measured: Melatonin measured every half hour for 5 hours at Early condition in all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Diabetic Disorder of Endocrine PancreasStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. MARTA GARAULET AZA, Universidad de Murcia
- Investigators
- Purificación Gomez Abellan, PHD, Study chair, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036592
- Sponsor's protocol ID
- 2017ES00001
- Acronym
- ONTIME-MT
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2017
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dozzani I, Rodriguez-Martin M, Dashti HS, Vetter C, Fernandez-Breis JT, Florez JC, Saxena R, Scheer FAJL, Garaulet M. Disrupted daily rhythms in light exposure and wrist temperature are associated with metabolic risk markers and obesity. Int J Obes (Lond). 2026 Oct 10. doi: 10.1038/s41366-026-02225-w. Online ahead of print.
PubMed 42859199Rodriguez-Martin M, Caballero FM, Dashti HS, Saxena R, Scheer FAJL, Fernandez Breis JT, Garaulet M. Objective prediction of siesta based on machine learning and association with obesity. Sleep Health. 2026 Jun;12(3):504-512. doi: 10.1016/j.sleh.2026.02.007. Epub 2026 Apr 9.
PubMed 41963146Longo-Silva G, Rodriguez-Martin M, Salmeron D, Scheer FAJL, Garaulet M. Optimal nap timing and body mass index: beyond duration. J Transl Med. 2026 Apr 1;24(1):693. doi: 10.1186/s12967-026-08049-6.
PubMed 41923243Garaulet M, Lopez-Minguez J, Dashti HS, Vetter C, Hernandez-Martinez AM, Perez-Ayala M, Baraza JC, Wang W, Florez JC, Scheer FAJL, Saxena R. Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. Diabetes Care. 2022 Mar 1;45(3):512-519. doi: 10.2337/dc21-1314.
PubMed 35015083
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population
- ClinicalTrials.gov ID
- NCT03036592
- Acronym / sponsor ID
- ONTIME-MT / 2017ES00001
- Keywords
- Glucose tolerance test, MTNR1B, nutrigenomics, food timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B) single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the deleterious effect in a vulnerable population with regular exposure to concurrent high melatonin and food intake as late night eaters (those having dinner within 2.5 h before their usual bed time). With the results from this study, we expect to advance our understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.
Detailed description
Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.
The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two glucose oral tolerance test (OGTT) conditions: a) delayed OGTT or Late Eating (LE): starting1 hour before their usual bed time, b) advanced OGTT or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.
These findings could support a clinical application for the screening of this SNP and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.
These goals will be achieved through a specific approach:
- Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance (n=1000).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Early OGTT, then late OGTT in MTNR1B CC | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early and Late conditions |
| Early OGTT, then late OGTT in MTNR1B CG | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions |
| Early OGTT, then late OGTT in MTNR1B GG | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions |
| Late OGTT, then Early OGTT in MTNR1B CC | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions |
| Late OGTT, then Early OGTT in MTNR1B CG | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions |
| Late OGTT, then Early OGTT in MTNR1B GG | Experimental | Behavioral: Early OGTT, Behavioral: Late OGTTOral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index: > 18.5 o < 40 kg/m2
- Age: between 18 and 65 year of age
- European ancestry
- Day workers
Key exclusion criteria (6 listed)
- Receiving treatment with thermogenic, lipogenic, or drugs
- Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
- Bulimia diagnosis, prone to binge eating
- Undergoing treatment with Type 2 diabetes mellitus (high blood sugar) medications such as Metformin or other non-Metformin oral anti-diabetic drugs such as sulfonylureas, meglitinides, or glitazones
- Undergoing treatment with Corticosteroids/steroids, Growth hormone, Anticoagulant medicines, or blood thinners, Beta blockers for hypertension, Medications for sleep, Fluvoxamine, Opioids or Amphetamines, Tranquilizers, nonsteroidal anti-inflammatory drugs.
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 |
|---|---|---|
| Early OGTTOral glucose tolerance test using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime) | Behavioural | Early OGTT, then late OGTT in MTNR1B CC, Early OGTT, then late OGTT in MTNR1B CG, Early OGTT, then late OGTT in MTNR1B GG, Late OGTT, then Early OGTT in MTNR1B CC, Late OGTT, then Early OGTT in MTNR1B CG, Late OGTT, then Early OGTT in MTNR1B GG |
| Late OGTTOral glucose tolerance test using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime) | Behavioural | Early OGTT, then late OGTT in MTNR1B CC, Early OGTT, then late OGTT in MTNR1B CG, Early OGTT, then late OGTT in MTNR1B GG, Late OGTT, then Early OGTT in MTNR1B CC, Late OGTT, then Early OGTT in MTNR1B CG, Late OGTT, then Early OGTT in MTNR1B GG |
Primary outcome
Area Under the Curve (AUC) Glucose
Time frame: Along 120 minutes in visits 1 and 2
Glucose levels are measured along 120 minutes corresponding to at early and late condition in each visit. The Area Under the Curve was calculated as the sum of the area of several trapezoids. This trapezoids was obtained at times 0-30 min, 30-60 min, 60-90 min, 90-120 min. The values are the difference between the late and the early condition.
Disposition Index (DI)
Time frame: Along 120 minutes in visits 1 and 2
Disposition Index (DI) is the product of insulin sensitivity times by the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. This index was determined by this formula: DI= CIR × ISI, where CIR is the measure Corrected Insulin Response, and ISI is Insulin Sensitivity Index. The values are the difference between the late and the early condition. Higher DI indicates an increased beta cell function and increased ability of the body to dispose of a glucose load.
6 secondary outcomes
Corrected Insulin Response (CIR)
Time frame: At minute 30 during the visit 1 and 2.
Insulin Sensitivity Index (ISI)
Time frame: Along 120min in visits 1 and 2
Fasting Glucose
Time frame: At minute 0 in visit 1 and 2.
Fasting Insulin
Time frame: At minute 0 in visit 1 and 2
Serum Melatonin
Time frame: At baseline and 120 minutes in visit 1 and 2
Dim Light Melatonin Onset (DLMO) at Early Condition Only
Time frame: Melatonin measured every half hour for 5 hours at Early condition in all participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42859199Dozzani I, Rodriguez-Martin M, Dashti HS, Vetter C, Fernandez-Breis JT, Florez JC, Saxena R, Scheer FAJL, Garaulet M. Disrupted daily rhythms in light exposure and wrist temperature are associated with metabolic risk markers and obesity. Int J Obes (Lond). 2026 Oct 10. doi: 10.1038/s41366-026-02225-w. Online ahead of print.
- Derived from this study: PubMed 41963146Rodriguez-Martin M, Caballero FM, Dashti HS, Saxena R, Scheer FAJL, Fernandez Breis JT, Garaulet M. Objective prediction of siesta based on machine learning and association with obesity. Sleep Health. 2026 Jun;12(3):504-512. doi: 10.1016/j.sleh.2026.02.007. Epub 2026 Apr 9.
- Derived from this study: PubMed 41923243Longo-Silva G, Rodriguez-Martin M, Salmeron D, Scheer FAJL, Garaulet M. Optimal nap timing and body mass index: beyond duration. J Transl Med. 2026 Apr 1;24(1):693. doi: 10.1186/s12967-026-08049-6.
- Derived from this study: PubMed 35015083Garaulet M, Lopez-Minguez J, Dashti HS, Vetter C, Hernandez-Martinez AM, Perez-Ayala M, Baraza JC, Wang W, Florez JC, Scheer FAJL, Saxena R. Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial. Diabetes Care. 2022 Mar 1;45(3):512-519. doi: 10.2337/dc21-1314.
- Individual participant dataSharing planned: No
Related trials for Non-Diabetic Disorder of Endocrine Pancreas
RecruitingObservational study
Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients
Pancreatectomy, Diabetes Mellitus Type 2
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.
Purificación Gomez Abellan, PHD study chair
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early OGTT and Late OGTT in people with Non-Diabetic Disorder of Endocrine Pancreas, run by Universidad de Murcia 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) Glucose (time frame: Along 120 minutes in visits 1 and 2). The study lists 2 primary outcomes in all. 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 NCT03036592, which also lists 4 linked publications.
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 16 Apr 2025.