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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05501093
Eligibility Criteria:
Inclusion Criteria:
* Men and women undergoing bariatric surgery who are 25-65 years old.
* BMI \> 35 kg/m2.
* Diabetic subjects: HbA1c\> 6.0% or fasting plasma glucose \>126 mg/dl).
* Normoglycemic subjects: HbA1c\<5.75% or fasting plasma glucose \<100 mg/dl).
* Dental criteria: Minimum of 4 posterior teeth.
* Signed and dated informed consent form.
* Willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria:
* Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA).
* Women who are considering pregnancy or are currently breastfeeding.
* Individuals with a history of chronic inflammatory or autoimmune diseases or taking medications that affect immune function or affect body weight such as chronic systemic steroids.
* Currently smoke more than 10 cigarettes per day.
* Periodontal treatment within 3 months of bacterial sampling.
* Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling.
* Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery).
* A treatment regimen of steroids within 1 month of sample collection.
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05501093
Study Brief:
Protocol Section:
NCT05501093