Clinical trial: A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide (NCT04407234)

Eligibility criteria:
Inclusion Criteria:

          -  Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²),
             inclusive at screening

          -  For nondiabetic subjects: as determined by medical history, physical examination, and
             safety assessments at screening

          -  For participants with a confirmed type 2 diabetes diagnosis: The condition must be
             managed either by diet and exercise alone or on a stable dose of metformin for the
             past 3 months

          -  Willing and agreeable to commit to the duration of the study and undergo study
             procedures as instructed by the clinic staff

        Key Exclusion Criteria

          -  Have undergone gastric bypass or bariatric surgery

          -  Have received prescription drugs or over the counter drugs that promote weight loss in
             the past 6 months prior to screening

          -  For participants with a confirmed type 2 diabetes diagnosis: Have experienced more
             than 1 episode of severe low blood sugar that require emergency treatment,
             hospitalization or third parties to administer rescue treatment, in the past 6 months

          -  Have any lifetime history of a suicide attempt

          -  Have other medical conditions or medical history that make participation in the study
             unsafe or which may interfere in the interpretation of the results of the study

          -  Unwilling to comply with smoking and alcohol restrictions during the study
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 65 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