N/A
N=845
MTNR1B SNP*Food Timing Interaction on Glucose Control
Non-Diabetic Disorder of Endocrine Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT03036592 ↗Enrolled (actual)
845
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Area Under the Curve (AUC) Glucose — 278.84; 268.92; 260.66; 282.21 mg*h/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early OGTT (Behavioral); Late OGTT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Murcia
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) Glucose |
278.84; 268.92; 260.66; 282.21; 274.91; 282.19 | — |
| PRIMARY Disposition Index (DI) |
3.44; 4.59; 5.04; 3.54; 3.83; 3.96 | — |
| SECONDARY Corrected Insulin Response (CIR) |
0.57; 0.70; 0.94; 0.58; 0.59; 0.53 | — |
| SECONDARY Insulin Sensitivity Index (ISI) |
7.36; 7.26; 6.42; 7.19; 7.40; 7.61 | — |
| SECONDARY Fasting Glucose |
85.25; 84.36; 84.05; 84.37; 84.69; 83.01 | — |
| SECONDARY Fasting Insulin |
6.70; 6.30; 6.88; 6.67; 6.16; 5.63 | — |
| SECONDARY Serum Melatonin |
20.86; 19.50; 20.25; 19.20; 19.01; 23.13 | — |
| SECONDARY Dim Light Melatonin Onset (DLMO) at Early Condition Only |
22.42; 22.03; 22.41; 22.50; 22.08; 22.39 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index: > 18.5 o < 40 kg/m2
- Age: between 18 and 65 year of age
- European ancestry
- Day workers
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03036592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.