Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lifestyle Management of CKD in Obese Diabetic Patients
Brief Summary: The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.


Options:
A: Inclusion Criteria:

* Age 40 years or older
* MDRD eGFR of 30-60ml/min/1.73m2 on ≥2 occasions ≥3 months apart
* Most recent eGFR measurement within 3 months Systolic blood pressure \<160mmHg and diastolic blood pressure \<95mmHg on three office blood pressure readings at time of screening and confirmed by a study ABPM before randomisation of \<150/90mmHg
* No change in anti-hypertensive or diuretic medications (including dose) for 3 months before screening visit
* Consumption of moderate sodium intake at screening, defined as an estimated daily sodium intake of \>2.3g/day estimated from food frequency questionnaire (FFQ) completed during the screening visit
* Self-reported willingness to modify dietary intake over sustained period, and adhere to directed recommendations over 2 years
* Signed written informed consent

Exclusion Criteria:

* Acute Kidney Injury in the preceding three months, defined as doubling of baseline serum creatinine or rapidly declining eGFR over the preceding six months, defined as a decline in eGFR of ≥10ml/min/1.73m2 in those with established CKD
* Any of the following renal conditions: glomerular disease due to post-infectious glomerulonephritis, IgA nephropathy, thin basement membrane disease, Henoch-Schonlein purpura, proliferative glomerulonephritis, membranous nephropathy (including lupus nephritis), rapidly progressive glomerulonephritis, minimal change disease, or focal segmental glomerulosclerosis
* Prior or planned renal transplantation
* Prior, current or planned renal dialysis
* Medical diagnosis known to be associated with abnormal renal sodium excretion, including Bartter syndrome, SIADH, diabetes insipidus, or serum sodium \<125mmol
* Severe heart failure (defined as left ventricular ejection fraction ≤30% or NYHA Class III/IV symptoms)
* High-dose loop or thiazide diuretic therapy, exceeding a total daily dose of frusemide 80mg, bumetanide 2mg, hydrochlorothiazide 50mg, bendroflumethiazide 2.5mg, indapamide 2.5mg, metolazone 2.5mg or the use of both a loop and thiazide diuretic
* Current use of non-steroidal anti-inflammatory drugs (NSAIDs) for 3 or more days per week. Low-dose aspirin \<100mg/day is not an exclusion
* Unable to follow educational advice of the research team
* Prescribed high-salt diet, low-salt diet or sodium bicarbonate
* Symptomatic postural hypotension or receiving treatment for postural hypotension
* Current or recent use (within one month) of immunosuppressive medications including tacrolimus, cyclosporine, azathioprine or mycophenolate mofetil
* Pregnancy or lactation
* Unable to comply with 24-hour urinary collections, or medical condition making collection of 24-hour urinary collection difficult (e.g. severe urinary incontinence)
* Participant unlikely to comply with study procedures or follow-up visits due to severe co-morbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in opinion of research team
* Cognitive impairment defined as a known diagnosis of dementia, or inability to provide informed consent due to cognitive impairment in the opinion of the investigator
* Body Mass Index (BMI) \<20kg/m2 or BMI\>40kg/m2
* Participating in another clinical trial or previous allocation in this study
B: Inclusion Criteria:

* Men or women at least 21 years of age: The lower age limit was chosen based on the National Institutes of Health (NIH) definition of adults for participation in research
* Any race or ethnicity: The investigators expect to recruit 50-60% African American and 40-50% non-African American (White, Hispanic, and Asian Americans), with the vast majority of the latter being non-Hispanic Whites.
* eGFR \< 90 mL/min/1.73m2 but \> 30 mL/min/1.73m2. The upper limit for eGFR was chosen to include participants with a clinically significant decrease in renal function. The investigators chose an upper eGFR limit slightly higher than the Kidney Disease Outcomes Quality Initiative (KDOQI) definition of moderately reduced glomerular filtration rate (GFR) to be more inclusive of patients with mild reduction in GFR but significant proteinuria. The lower eGFR limit was set to exclude patients with advanced CKD, where the potential effects of dietary sodium reduction on proteinuria may not be apparent or greatly alter CKD progression. The eGFR to define eligibility will be calculated using calibrated serum creatinine values and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimating equation.
* Albumin-to-creatinine ratio \> 30mg/g

Exclusion Criteria:

* Albuminuria ≥1.5 g/g or kidney structural change
* Prior kidney transplant based on self-report
* Immunosuppression or other immunotherapy within the past six months prior to enrollment based on patient self-report
* History of cancer other than non-melanoma skin cancer within two years prior to enrollment based on patient self-report
* History of polycystic kidney disease
* Currently receiving dialysis treatment
* History of human immunodeficiency virus (HIV)
* Current pregnancy, breastfeeding or plans to become pregnant during the study
* Consumption of ≥14 alcoholic drinks/week or consumption of ≥6 drinks/occasion
* Current participation in another lifestyle intervention trial
* Current residence or planned residence make it difficult to meet trial requirements
* Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator
C: 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:

* Investigators will exclude from participation those with the following characteristics:

  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
  7. unable to walk 0.25 miles in 10 minutes
  8. a major psychiatric disorder
  9. planning gastric bypass surgery in the next 12 months
  10. 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).
* Investigators will exclude from the study those with underlying diseases that 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.
* 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.
D: Inclusion Criteria:

* Patients who have received a kidney transplant ≥ 6 months previously who have a BP \>130 mm Hg systolic and/or \>80 mm Hg diastolic, or are receiving treatment for hypertension.

Exclusion Criteria:

* BP \< 120/80 on blood pressure treatment
* BP \>160/100
* Variation in Creatinine \>20% over preceding 2 months
* Secondary hypertension due to a cause other than CKD
* Heart failure (LVEF \<30% or NYHA class II - IV)
* Myocardial Infarction within 6 months
* Stroke within 6 months
* Current diagnosis of cancer
* Liver disease
* Bilateral arterio-venous fistulae
* Evidence of significant active infection
* Females who are pregnant or breastfeeding
* Hyponatremia (Na \<130mmol/L) or Hypernatremia (Na \>150mmol/L)
* Histologically confirmed episode of rejection within 6 months
* Steroids dose change in preceding 2 months
* Patients who are not able to give full informed consent
* Initial 24hr urinary sodium \<80mmol/24hrs

Answer: C