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:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT03805412
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-55
2. Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
3. BMI ≥ 30 kg/m2
4. Willing to wear pedometer during study period
5. Able to walk 2 city blocks at baseline without assistance (self-reported)
6. Reading level at least 6th grade in English
7. Expected to remain in local community for at least 4 months
8. Either is not treated with or has been on a stable treatment regimen of any of the following medications for a minimum of 3 months prior to Visit 1 (Screening/Enrollment):
1. Sulfonylureas
2. Biguanidine
3. Thyroid replacement therapy
4. Glp-1 agonists
5. Sodium-glucose co-transporters
6. Basal insulin
7. Thiazolidinediones
8. Hormone replacement therapy (female subjects) estrogen/progesterone products
9. Oral contraceptives/birth control (female subjects)
10. Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.)
9. Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), communicate with the investigator, and understand and comply with protocol requirements.
Exclusion Criteria:
1. Women who are pregnant, lactating, planning to become pregnant
2. Subjects who are taking amphetamines, anabolic, or weight-reducing agents
3. Contraindications to moderate exercise
4. Pre-prandial insulin
5. On any antipsychotic medication or history of schizophrenia or bipolar disorder
6. Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months
7. Active wounds or recent surgery within 3 months
8. Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics
9. Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study
10. Presence or history of severe congestive heart failure (New York Heart Association Class IV \[CCNYHA 1994\])
11. Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
12. Enrolled in another weight loss program
13. Already receiving continuous glucose monitoring (CGM)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03805412
Study Brief:
Protocol Section:
NCT03805412