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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT06424132
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 years old and 35
2. Lean group: BMI is between 18.5 and 24.9. HgA1c \<5.7%
3. Obese group: BMI is \>30, HgA1c \<5.7%
4. Obese group with Type II diabetes: BMI is \>30, HgA1c is \>6.5% If on oral medication for diabetes management, HgA1c may be \< 6.5% The following medications are also acceptable: statins, aspirin, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARB).
Exclusion Criteria:
1. Diabetes type I (self-report)
2. Diagnosis of thyroid disease (including goiter, hyperthyroidism, hypothyroidism, thyroiditis)(self-report)
3. Diagnosis with cancer including skin cancer (self-report)
4. Diagnosis or evidence of Raynaud's Syndrome or systemic sclerosis (self-report)
5. A recent diagnosis of Coronavirus Disease 2019 (COVID-19) (last 2 weeks) or hospitalized at the time of diagnosis with COVID-19
6. Any vaccine administration within two weeks preceding the study procedure
7. Currently pregnant
8. Currently taking any prescribed medication other than oral contraceptives. Treatments for weight loss or any other supplements that may alter weight or metabolism are not acceptable. Vitamins are acceptable.
9. Has consumed nicotine (smoking, inhaling, ingesting) within the last 6 months
10. Has used illicit drugs within the last 6 months (marijuana users are eligible unless consumed in the last 30 days).
11. Any medical, psychological, or social condition that, in opinion of principle investigators, would jeopardize the health or well-being of the participant during the study procedure or the integrity of the data
12. Diabetes Type II that is managed by insulin.
13. Steroid use in the last 30 days to the exclusions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06424132
Study Brief:
Protocol Section:
NCT06424132