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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT04663061
Eligibility Criteria:
Inclusion:
* Individuals with T2DM diagnosed within the past 6 years
* Body Mass Index (BMI) of 30-39.9 kg/m2.
* Participants must have an HbA1c between 6.5-11.9%.
* Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling.
Exclusion criteria:
* Poorly controlled depression
* Recent hospitalization for psychosis or bipolar disorder
* Poorly controlled blood pressure (\>159/99)
* Prior surgical procedure for weight control or liposuction
* Unable to make changes to their diet
* Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests)
* Use of weight loss medications in previous 3 months
* Recent self-reported weight change (+/- 15lbs)
* Current use of oral corticosteroids more than 5days/month
* Cardiovascular disease event within the past 6 months
* Severe pulmonary disease requiring supplemental oxygen
* Renal failure (end stage renal disease)
* History of non-skin cancer in the past 5 years
* Major liver dysfunction within the last 2 years
* Recently quit smoking less than 6 months prior
* Inability to attend visits and adhere to study protocols
* Pregnancy or currently lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04663061
Study Brief:
Protocol Section:
NCT04663061