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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07455435
Eligibility Criteria:
Inclusion Criteria:
Adults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) \>= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days
Exclusion Criteria:
Diabetes and Glycemic Management:
* Diagnosed type 1 or type 2 diabetes mellitus
* Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)
* HbA1c \>= 6.5% or fasting plasma glucose \>= 126 mg/dL
Cardiovascular Conditions:
* History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)
* Peripheral artery disease
* Uncontrolled hypertension (systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg)
* Raynaud phenomenon or other conditions affecting peripheral vascular assessment
* Atrial fibrillation or other arrhythmias affecting pulse wave velocity measurement
Medications Affecting Vascular Function:
* Current use of vasoactive medications (nitrates, phosphodiesterase inhibitors)
* Recent changes (\< 4 weeks) in antihypertensive medications
* Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Systemic corticosteroid use
Physical Activity Limitations:
* Physical disability or musculoskeletal condition preventing normal ambulation
* Use of mobility aids (wheelchair, walker, cane)
* Medical advice to limit physical activity
Other Exclusions:
* Pregnancy or lactation
* Active cancer or cancer treatment within the past 5 years (excluding non-melanoma skin cancer)
* Chronic kidney disease (eGFR \< 60 mL/min/1.73m2)
* Liver disease (ALT or AST \> 3x upper limit of normal)
* Thyroid disease (unless stable on treatment for \> 3 months)
* Current participation in a weight loss program or clinical trial
* Skin conditions preventing CGM sensor placement
* Known allergy to CGM adhesive
* Shift work or irregular sleep schedule (may affect CGM patterns)
* Planned travel during study period that would interfere with study visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07455435
Study Brief:
Protocol Section:
NCT07455435