Intervention: Aliskiren
Trial phase: Not Applicable
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Aliskiren: 150mg tablet, taken orally for 12 weeks daily
Eligibility criteria:
Group 1. Subjects At Risk of Developing Type 2 Diabetes

INCLUSION CRITERIA

Ages of 21-80 years
Subjects "at risk" of developing type 2 Diabetes Mellitus (First degree relatives history of type 2 Diabetes Mellitus, History of gestational Diabetes, Known impaired glucose tolerance, Impaired fasting plasma glucose 100-126 mg/dl at the time of enrollment)

EXCLUSION CRITERIA

Treatment with Aliskiren (Tekturna)
Smokers (use of tobacco products in the previous 3 months)

Active or Uncontrolled Cardiovascular Disease

Myocardial infarction, or angina within 12 months of study participation
Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)
Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
History of previous hypotensive episodes
Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
Hyperkalemia (serum potassium >5.0 meq/L)
Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
Any Other Serious Chronic Disease Requiring Active Treatment
Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
Pregnancy

Taking Any of the Following Medications:

Systemic (not inhaled) Glucocorticoids
Antineoplastic Agents
Cyclosporine, Ketoconazole, Furosemide, Warfarin
Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations

Group 2. Type 2 Diabetic Patients

INCLUSION CRITERIA

Ages of 21-80 years
Type 2 Diabetes Mellitus stable and not expected to change during the study period

EXCLUSION CRITERIA

Treatment with Aliskiren (Tekturna)
Smokers (use of tobacco products in the previous 3 months)

Active or Uncontrolled Cardiovascular Disease

Myocardial infarction, or angina within 12 months of study participation
Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)
Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
History of previous hypotensive episodes
Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
Hyperkalemia (serum potassium >5.0 meq/L)
Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
Any Other Serious Chronic Disease Requiring Active Treatment
Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
Pregnancy

Taking Any of the Following Medications:

Systemic (not inhaled) Glucocorticoids
Antineoplastic Agents
Cyclosporine, Ketoconazole, Furosemide, Warfarin
Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations
Severe proliferative retinopathy that renders the subject legally blinded
Previous diagnosis of severe gastroparesis diabeticorum due to autonomic neuropathy that has necessitated hospital admission
Presence of non-healing foot ulceration due to severe peripheral diabetic neuropathy
Documented diabetic nephropathy manifested as macro-albuminuria, (2 of 3 urine specimens collected within a 3-6 month period with urine albumin>300 ug/mg creatinine