Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: Inclusion Criteria:

* Diagnosis of uncontrolled hypertension,
* prescribed a medication to lower blood pressure,
* have a regular primary care physician at Durham VA Medical Center, and
* be a veteran. For Sustainability portion the patient must have participated in an intervention arm of primary study.

Exclusion Criteria:

* Hospitalized in past 3 months for stroke,
* heart attack,
* surgery for blocked arteries,
* diagnosed with metastatic cancer or treated with dialysis,
* have a diagnosis of dementia or a hearing impairment which prevents them from being able to hear/speak on the telephone, and
* creatinine serum lab which exceed 2.5.
B: Inclusion Criteria:

Screening study: Every one aged 40-69 years (UK and DK) or 50-69 years(NL). Treatment study: All with screen detected type 2 diabetes.

Exclusion Criteria:

Participants are excluded if they already have diabetes at time of screening, are pregnant or lactating or have a severe psychotic illness, are house bound or have an illness with a likely survival of less than one year.
C: Inclusion Criteria:

* Age ≥ 40 years
* History of diabetes mellitus type 2 for at least three months with stable antidiabetic treatment
* Systolic and/or diastolic blood pressure ≥ 135 or 85 mmHg, respectively. In alternative, antihypertensive therapy regardless of blood pressure values
* Serum creatinine ≤ 1.5 mg/dL
* Urinary albumin excretion rate \< 200 µg/min
* Written informed consent for the trial participation.

Exclusion Criteria:

* Clinical or histological evidence of non-diabetic renal disease, including vascular disease of the kidney, obstructive uropathy, prostatic hypertrophy or incomplete bladder emptying
* Transplanted kidney
* Moderate to severe chronic heart failure (III-IV stage according to the NYHA classification).
* Cerebral hemorrhage, stroke or transient ischemic attack within three months prior to the trial enrolment
* Myocardial infarction within three months prior to the trial enrolment
* Unstable angina pectoris
* Mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
* Secondary (e.g., Cushing disease, phaeochromocytoma, etc.) or severe refractory hypertension
* Poor glycemic control (HbA1c\>11%)
* Connective tissue or autoimmune disease
* Hereditary angioneurotic edema
* Clinically relevant electrolyte imbalance (e.g., serum potassium \> 5.5 mmol/L)
* Clinically relevant hematological disorders
* Anemia with hemoglobin concentrations \< 10 g/dL
* Serious hepatic disease
* Pregnancy or lactating or planning a pregnancy
* Women of childbearing potential without following a scientifically accepted form of contraception
* Any other serious or terminal concomitant disease
* Any condition which may interfere with the absorption of the study treatments
* Any concomitant treatment with ACE inhibitors, angiotensin II blockers, calcium channel blockers, potassium sparing diuretics
* Chronic treatment with nonsteroidal antiinflammatory drugs, antidepressants and neuroleptics, lithium, cimetidine, immunosuppressive and/or antineoplastic drugs, chronic systemic glucocorticoid therapy more than 7 consecutive days in one month, antiarrhythmic drugs (e.g., chinidin, procainamide), anesthetics/narcotics
* History of hypersensitivity to delapril or other ACE inhibitors, manidipine or other dihydropyridine CCBs
* Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
* Evidence of an uncooperative attitude
* Any evidence that allows predicting that the patient will not be able to complete the trial follow-up.
D: Inclusion Criteria:

* Type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.
* Duration of diabetes for \> 1 year and \< 15 years with stable diabetic therapy within last 6 months.
* Patients with untreated resting mean sitting SBP \< 130 mmHg, mean sitting DBP \< 85 mmHg and with retinal photograph grading level 10/10 (on ETDRS severity scale).

Exclusion Criteria:

* Patients with the following conditions are excluded from participation in the study:
* Cataract or media opacity of a degree which precludes taking gradable retinal photographs
* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
* History of retinopathy
* History or presence of clinical significant macular oedema (CSME)
* History or evidence of photocoagulation of the retina Other retinal conditions which may mask assessment, eg, retinal vein occlusion
* Positive micral dipstick test
* Presence of secondary diabetes
* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
* Need of treatment with ACE-inhibitor
* Haemodynamically significant aortic or mitral valve stenosis
* Known renal artery stenosis or kidney transplantation
* Hypersensitivity to study drug
* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator

Answer: C