Diabetes mellitus type 2 Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Participants will be followed up for approximately 14 months. Each participant will be randomized to either placebo or Valsartan 160 mg/day for the first six months and then given the opposite treatm
Sponsors
Beth Israel Deaconess Medical Centre (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We plan to study two groups with 15 subjects each: 1. Healthy non-diabetic subjects 2. Patients with type 2 diabetes with no severe long-term diabetes complications For inclusion in the trial, patients must fulfil all of the following criteria: 1. All subjects will be ages 21-80 years 2. Healthy subjects - subjects should not be considered at higher risk than the general population to develop type 2 diabetes according to one of the following criteria: a. Fasting plasma glucose 200 mg/dl with symptoms suggestive of hyperglycemia (polyuria, polydipsia, weight loss) b. Fasting plasma glucose levels >126 mg/dl c. Two-hour plasma glucose >200 mg/dl during a 75 gm OGTT In the absence of unequivocal hyperglycemia with acute metabolic decompensation, these criteria should be confirmed by repeat testing on a different day. 5. Prior to participation in this study, each subject must sign an informed consent form
Exclusion criteria
Exclusion criteria: Active or uncontrolled cardiovascular disease as follows: a. Coronary artery disease (CAD) (known CAD with previous diagnosis of definite acute myocardial infarction, unstable angina or stable angina) b. Arrhythmia (uncontrolled, highly symptomatic, requires treatment or life-threatening) c. Congestive heart failure (CHF) (New York Heart Association function class III and IV - symptoms of heart failure on less than ordinary exertion or at rest) d. Stroke or transient ischemic attack with residual neurological damage e. Uncontrolled hypertension: systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >105 mmHg (two abnormal readings during visit) f. Hypotension 2. Liver disease (alanine aminotranferease (ALT), aspartate aminotransferase (AST), alkaline phosphate levels >2 times upper normal limit) at the time of enrolment 3. Renal disease (macro-albuminuria) (2 of 3 urine specimens collected within a 3-6 month period with urine albumin =300 ug/mg creatinine - according to the American Diabetes Association (ADA) position statement) 4. Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl). Subjects with hypertriglyceridemia may be re-tested in 2-3 weeks as the values can fluctuate tremendously within a few days. In the event that the re-tested value allows the patient to be enrolled, a planned deviation will be submitted to the Cardiovascular Credentialing International (CCI). 5. Any other serious chronic disease requiring active treatment 6. Females of childbearing potential not using an effective form of birth control as determined by the investigators 7. Subjects on any of the following medications: a. Angiotensin II receptor antagonist treatment during last 3 months b. Systemic glucocorticoids c. Antineoplastic agents d. Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis 8. Claustrophobia 9. Subjects unable to have magnetic resonance imaging (MRI) scan according to the MRI clinical standards such as a pacemaker, defibrillator, eye implants and other metal implants or devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in aortic elasticity (arterial compliance, stiffness index and pulse wave velocity) measured by MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ventricular function (the volumetric assessment of mass, end-diastolic and end-systolic volumes, ejection fraction (EF), stroke volume and cardiac output of the left and the right ventricles) | — |
Countries
United States of America
Outcome results
None listed