Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition I… (NCT06932289) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
United States54 participantsStarted 2025-05-01
Plain-language summary
It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* United States Veterans
* Male or female, age 18-55 years at the time of signing informed consent.
* at least 2 of the following: waist circumference \> 40" for men and 35" for women, FBS \>100 mg/dl, triglycerides \> 150 but \< 500 mg/dL, HDL \< 40 mg/dL, Pre- hypertension or hypertension (BP\>120/80 mmHg but \<150/90 mmHg)
Exclusion Criteria:
* History of diabetes require medications
* History of alcohol intake ≥ 20g/day
* History of cirrhosis
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \<30 mL/min/1.73 m2
* History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
* Any unstable medical conditions or terminal diagnosis.
* Any participant who is unwilling to sign an informed consent form will not be admitted into the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of glucose
Timeframe: From enrollment to the end of measurement at 12 weeks
2
Concentration of cholesterol
Timeframe: From enrollment to the end of measurement at 12 weeks
3
Concentration of triacylglycerol (TG)
Timeframe: From enrollment to the end of measurement at 12 weeks]
4
Concentration of Nitric oxide (NO)
Timeframe: From enrollment to the end of measurement at 12 weeks
5
Measurement of heart rate (HR)
Timeframe: From enrollment to the end of measurement at 12 weeks
6
Measurement of heart rate variability (HRV)
Timeframe: From enrollment to the end of measurement at 12 weeks
7
Measurement of pulse wave velocity (PWV)
Timeframe: From enrollment to the end of measurement at 12 weeks