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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT03832933
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age ≥18 years
* T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)
* BMI of ≥27 kg/m2
* Weight stable (±3kg in the last 3 months)
* Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage
* Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period.
Exclusion Criteria:
* HbA1c concentration of ≥12%.
* Pregnant or lactating within the past 6 months or trying to become pregnant.
* Individuals following a vegetarian/vegan only diet
* Food allergies (to red meats or other common protein sources)
* Using exogenous insulin for T2D management
* Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study.
* Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
* Current Eating disorder (anorexia or bulimia)
* Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable.
* Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03832933
Study Brief:
Protocol Section:
NCT03832933