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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03036592 |
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Date of registration:
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26/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MTNR1B SNP*Food Timing Interaction on Glucose Control
ONTIME-MT |
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Scientific title:
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MTNR1B SNP*Food Timing Interaction on Glucose Control in a Late Eater Mediterranean Population |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03036592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Marta Garaulet, PHD |
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Address:
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Telephone:
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678996368 |
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Email:
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garaulet@um.es |
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Affiliation:
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Name:
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Marta Garaulet, PHD |
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Address:
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Telephone:
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678996368 |
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Email:
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garaulet@um.es |
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Affiliation:
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Name:
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Purificación Gomez Abellan, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de Murcia |
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Key inclusion & exclusion criteria
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IInclusion Criteria:
- Body Mass Index: > 18.5 o < 40 kg/m2
- Age: between 18 and 65 year of age
- Caucasian
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-Diabetic Disorder of Endocrine Pancreas
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Intervention(s)
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Behavioral: Late OGTT
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Behavioral: Early OGTT
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Primary Outcome(s)
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Disposition index
[Time Frame: between 0-120 minutes, Visit 2 and 3]
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Area Under the Curve (AUC) glucose
[Time Frame: between 0-120 minutes, Visit 2 and 3]
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Secondary Outcome(s)
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DLMO
[Time Frame: between 0-5 hours, Visit 3]
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Corrected Insulin Response
[Time Frame: between 0-120 minutes, Visit 2 and 3]
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Fasting glucose
[Time Frame: between 0-120 minutes, Visit 2 and 3]
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Serum Melatonin
[Time Frame: at baseline and 120 minutes, Visit 2 and 3]
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Fasting insulin
[Time Frame: 0-120 minutes, Visit 2 and 3]
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Insulin Sensitivity Index
[Time Frame: between 0-120 minutes, Visit 2 and 3]
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Secondary ID(s)
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2017ES00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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