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 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT04194450
Eligibility Criteria:
Inclusion Criteria:
* physician-diagnosed type 2 diabetes of ≥1 year
* current hemoglobin A1C (HbA1c) of 6.5-8.0%
* treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
* blood pressure of \<160/99 mm Hg assessed according to guidelines
* non-smoking
* no prior history of cardiovascular disease or stroke
* not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
* 20-75 years old
Exclusion Criteria:
* being a competitive endurance athlete
* taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
* being unable to travel to and from the university
* being unable to follow the controlled diet instructions
* being pregnant or planning to become pregnant during the study (if female)
* disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
* being unable to read or communicate in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT04194450
Study Brief:
Protocol Section:
NCT04194450