Clinical trial: Study on the Mechanism of Regulating Gut Microbiome in Obese People by Regulating Brain-gut Axis With Fast Diet (NCT04691583)

Eligibility criteria:
Inclusion Criteria:

          1. BMI greater than or equal to 28 kg/m2, waist circumference greater than or equal to
             90cm for men and 85cm for women.

          2. Aged between 18 and 60.

          3. Patients may be accompanied by diseases such as abnormal blood pressure, abnormal
             blood lipid, abnormal uric acid, metabolic syndrome, respiratory sleep, constipation,
             etc., but they can only participate in these diseases if there is no obvious risk
             after clinical evaluation.

          4. No serious heart, brain, liver and kidney dysfunction, uremia coma, ketoacidosis,
             hypoglycemia, anemia, malnutrition, hematopoietic system and body immune system
             diseases, infectious diseases, neurological diseases.

        5, the body does not contain the implantation or other metal materials such as the
        implantable metal denture, cardiac pacemaker, artificial joint, insulin pump and so on, no
        claustrophobia, non-pregnancy, suitable for magnetic resonance examination to participate
        in.

        Exclusion Criteria:

          1. those who do not meet the above diagnostic criteria have poor compliance and have not
             signed a voluntary informed consent to participate in the experimental study.

          2. patients with severe cardiac, cerebral, hepatic and renal dysfunction, uremia coma,
             ketoacidosis, hypoglycemia, anemia, malnutrition, hematopoietic system and physical
             immune system diseases, infectious diseases, neurological diseases, etc.

          3. special groups such as female menstruation, minors, pregnant women, and the elderly
             over 60 years old.
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 60 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