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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT04862234
Eligibility Criteria:
Inclusion criteria:
* Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery
* BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c
Exclusion criteria:
* Patients prescribed or taking antihyperglycemic medications
* Patients undergoing cardiac surgery or patients anticipated to require ICU care
* Patients expected to be admitted less than 48-72 hours after surgery
* Severely impaired renal function (eGFR \< 30 mL/min) or clinically significant hepatic failure
* Treatment with oral (equivalent to prednisone \> 5 mg/day) or injectable corticosteroids
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; unable to consent
* Pregnant or breast feeding at time of enrollment
* Prisoners
* Patients undergoing gastrointestinal surgery or at high risk for gastrointestinal obstruction/ileus or expected to require gastrointestinal suction
* Patients with delayed gastric emptying, pancreatic or gallbladder disease
* Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT04862234
Study Brief:
Protocol Section:
NCT04862234