Clinical trial: Diabetes CKD Lifestyle Technology Study (NCT02266823)

Eligibility criteria:
Inclusion Criteria:

          -  In order to be eligible for the study, the individual must be 40 years of age or
             older; have a DRG Code of T2DM, GFR of 15-89 ml/min/1.73m2 and a BMI >30 kg/m2. The
             participant's physician of record will have verified that his/her patient can safely
             participant in an intervention study that involves weight loss and a goal of 150
             minutes/week of moderate physical activity (comparable to brisk walking).

        Exclusion Criteria:

          -  Those with the following characteristics will be excluded by the investigators:

               1. unable or unwilling to provide informed consent; (2) unable to participate
                  meaningfully in an intervention that involves group sessions (e.g., due to
                  uncorrected hearing impairment, non-English-speaking); (3) unable to read or
                  otherwise use an iPad to monitor dietary intake, physical activity, and weight
                  (e.g., blind, illiterate); (4) unwilling to accept randomization assignment; (5)
                  pregnant, or plans to become pregnant in the next 12 months, less than 3 months
                  postpartum, or nursing or within 6 weeks of having completed nursing; (6) weight
                  loss of > 10% in the past 6 months except for postpartum weight loss; and (7)
                  individuals who are institutionalized (e.g., in a nursing home or personal care
                  facility, or those who are incarcerated and have no control over their diet).

        will exclude from the study those with underlying diseases which would increase the risk of
        participating in an intervention involving caloric restriction and physical activity. Such
        individuals would include those requiring treatment for cancer, exclusive of skin cancer
        other than melanoma, in the past 2 years; infectious diseases including untreated AIDS and
        active tuberculosis; uncontrolled hypertension of >190 mmHg SBP or >105 mmHg DBP despite
        treatment; stroke or TIA in the past 6 months; conditions requiring the use of home oxygen;
        or other chronic disease or condition likely to limit life span to < 1 year. A recent
        Institute of Medicine report suggests that reducing dietary sodium below 1,840 mg/day in
        those with mid- to late-stage heart failure may increase adverse events or mortality. Thus
        investigators will exclude those with heart failure.

        Because of the dietary requirements of a pregnant woman, and the nature of weight loss and
        gain with pregnancy, inclusion of pregnant women in the study would confound the study
        results. Those who become pregnant during the study will be withdrawn from 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 40 Years old.


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