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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT07189234
Eligibility Criteria:
Inclusion criteria:
1. Age: 18-75 years
2. HbA1c: 5.7% to 7.0%
3. Metabolic syndrome (must meet 3 criteria): Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg (required) and 2 of the following:
* Elevated waist circumference:
* In Asians: ≥ 90 cm in men, ≥80 cm in women
* In all other races: ≥ 102 cm in men, ≥ 88 cm in women
* Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides
* Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol
* Fasting glucose ≥ 100 mg/dL
4. Own a smartphone (Apple iOS or Android OS)
5. Baseline eating period ≥12 hour/day
6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, GLP-1R agonists and SGLT2 inhibitors) for at least 3 months are allowed.
Exclusion Criteria:
1. Use of sulfonylurea or insulin.
2. HbA1C \> 7.0%
3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
5. Shift workers with variable (e.g. nocturnal) hours.
6. Frequent travel to different time zones during the study period.
7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse.
8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack).
9. Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)
10. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
11. History of adrenal disease.
12. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
13. Known history of type 1 diabetes.
14. History of an eating disorder.
15. History of cirrhosis.
16. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
17. Currently enrolled in a weight-loss or weight-management program.
18. On a special or prescribed diet for other reasons (e.g. Celiac disease).
19. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07189234
Study Brief:
Protocol Section:
NCT07189234