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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05205005
Eligibility Criteria:
Inclusion Criteria:
1. 45-74 years of age at the time of enrollment
2. Diagnosis of T2D by a health care provider, confirmed by chart review
3. HbA1c \<9% and fasting blood glucose \<200 mg/dL at screening visit
4. Body mass index (BMI) 25-45 kg/m2
5. Women should be postmenopausal (absence of menses for at least 1 year)
6. Sedentary subjects (\<2 days/week of vigorous exercise)
7. Willingness to follow up instructions provided by study team
Exclusion Criteria:
Exclusion:
1. Evidence of cardiac arrhythmias, unstable angina (or other cardiac event), heart failure or stroke in the last 12 months
2. Evidence of chronic kidney disease stage IV or V (GFR \<30 mL/min)
3. Evidence of uncontrolled hypertension, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg on more than 2 occasions in the past 12 months or at screening visit
4. Diagnosis of chronic liver disease
5. Uncontrolled thyroid dysfunction (abnormal TSH within 3 months of study enrollment)
6. Active cancer
7. Current use of hormone replacement therapy
8. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
9. Current pregnancy or intent to become pregnant during the course of the study
10. Inability to swallow capsules
11. Known allergies to any of the compounds in the supplement: glucosamine extract, fucoidan extract, olive extract, artichoke extract, red and white grapes extract, melon concentrate, hyaluronic acid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
64 Years
Study:
NCT05205005
Study Brief:
Protocol Section:
NCT05205005