Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT04259632
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥30 and ≤ 55 kg/m\^2
* Own a smartphone compatible with the myCircadianClock (mCC) phone application
* Self-reported habitual wakening between 5-9 am
* Self reported sleep duration of 6-9 hours
* Weight must be stable \[+/- 5 pounds\] for at least 3 months prior to the study
* Eating window (time between 1st food intake and last food take) ≥14 hours using mCC
* Insulin resistance based on HOMA-IR≥ 2.5 from screening visit results
* Able to understand English
Exclusion Criteria:
* Use of beta-blockers or medications known to affect weight, such as thiazolidinedione (TZD), insulin, glucagon-like peptide (GLP)-1 agonists, phentermine, or sibutamine
* Shift work (i.e. working from 11pm to 7am)
* Clinically significant medical issues (diabetes, cardiovascular disease, uncontrolled pulmonary disease)
* A history of abnormal laboratory results, such as hematologic (platelets \< 100), hepatic (LFTs \> 2X nl), renal (Cr \> 1.5)
* MRI contraindication (metal in body, claustrophobia)
* Eating window \< 12 hours per day
* Unable to consistently document food intake using the mCC app (need at least 2 eating occasions\> 6 hours apart on a given day for at least 50% of days)
* Pregnancy
* Illiteracy
* Concern for active eating disorder per screening questionnaire
* Self-reported eating disorder or history of eating disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04259632
Study Brief:
Protocol Section:
NCT04259632