Clinical trial: EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (NCT04531176)

Eligibility criteria:
Inclusion Criteria:

          1. Gender: men and women

          2. Ethnicity: all ethnic groups

          3. Age: ≥18, < 75 years

          4. Diagnosis of T2D -A1C within the last 90 days must be >7.5%

          5. Obesity, BMI ≥30

          6. An Employee, or the significant other of an employee, that is covered by the Cleveland
             Clinic Employee Health Plan

        Exclusion Criteria:

          1. Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)

          2. Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney
             Disease Epidemiology Collaboration Equation, CKD-EPI)

          3. Current glucocorticoid therapy

          4. Currently or within the past 3 months receiving an anti-obesity medication, or any
             other medication used for the primary intent of weight loss

          5. Any condition, unwillingness or inability, not covered by any of the other exclusion
             criteria, which, in the study clinician's opinion, might jeopardize the subject's
             safety or compliance with the protocol

          6. Mental incapacity or language barrier

          7. Pregnancy or plans to become pregnant within the next 2 years

          8. Personal or family history of medullary thyroid carcinoma

          9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2

         10. History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of
             digestive tract

         11. History of congestive heart failure

         12. History of bariatric or metabolic surgery/procedure

         13. Visit with an endocrinologist within the past 1 year

         14. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight
             Management Program
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment