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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT03527368
Eligibility Criteria:
Inclusion Criteria:
* Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9%
* Class I-III obesity (BMI 30-50 kg/m2)
* If on medications for hypertension, stable regimen for at least past 6 months
* Willingness to adjust timing of feeding
* Willingness and ability to eat study diet and nothing else during run-in and intervention
* Willingness to complete measurement procedures
Exclusion Criteria:
* Moderate to severe obstructive sleep apnea
* Shift work;
* Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep \<6 hours/night
* Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol)
* Renal dysfunction (estimated Glomerular Filtration Rate (GFR) \<30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34)
* Use of glucose-lowering medications, weight loss medications, medications for sleep disorders (sedative/hypnotic drugs, stimulants), lithium, systemic corticosteroids, diuretics, blood thinners requiring regular monitoring (e.g. warfarin), anti-psychotic drugs and antiretroviral therapy
* Body weight \>400 pounds (limitation of facility scales)
* \>1 drink per day of alcohol
* Active substance use disorder or significant psychiatric/psychologic disorder that would interfere with participation
* Significant food allergies, preferences, intolerances, or dietary supplements that would interfere with diet adherence
* Weight loss or gain of ≥5% during past 6 months
* Pregnant, planning to become pregnant, or breastfeeding
* Planning to start a weight loss program
* Planning to leave the area prior to end of study
* Current participation in another clinical trial
* Cancer diagnosis requiring active treatment in past two years or planned treatment (with exception of localized non-melanoma skin cancer)
* Active inflammatory bowel disease, malabsorption, or history of major gastrointestinal surgery involving bowel resection
* Myocardial infarction or stroke in past 6 months
* Prior bariatric surgery
* Any serious illness that would interfere with participation
* Other conditions or situations at the discretion of the PI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
69 Years
Study:
NCT03527368
Study Brief:
Protocol Section:
NCT03527368