Expired Study
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Baltimore, Maryland 21201


Purpose:

The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance. Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.


Study summary:

Several studies have demonstrated that therapeutic agents used to reduce glucose levels and/or weight can delay the onset of type 2 diabetes. Intriguingly, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) also result in reduction in the onset of type 2 DM. The most striking effect was found with Ramipril in the HOPE study. The onset of new type 2 DM was reduced by 34% (p<0.001) as compared to placebo. Furthermore, the results of the DREAM trial demonstrate that Ramipril at a dose of 15 mg can significantly reverse impaired glucose tolerance. However, the mechanisms underlying Ramipril effects to delay type 2 diabetes are not known. The proposal will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 DM and restoring normal glycemia in patients with impaired glucose tolerance. The specific aims of the project are: - to determine the effect of Ramipril on insulin resistance at the level of the liver and peripheral tissues, - to determine the effect of Ramipril on endothelial function, - to determine the effects of Ramipril on insulin secretion, and - to determine the effects of Ramipril on substrate flux, lipolysis and inflammatory cytokines.


Criteria:

Inclusion: - 48 (24 male / 24 female) with impaired glucose tolerance. - Impaired blood glucose values as outlined by the American Diabetes Association guideline. Fasting plasma glucose between 100 and 126 mg/dl or 2 hour post prandial glucose between 140 and 200 mg/dl - BMI > 25 kgM2 - Age: 20-65 years - Treated or Untreated hypertension defined as measurement of seated BP at screening visit of systolic BP 120 to 150 and/ or diastolic BP 80 to 100. Exclusion: - Patients receiving agents that can increase or lower blood glucose, i.e., metformin, thiazolidinediones, sulfonylureas, glitinides, acarbose, GLP-1 receptor agonists - Untreated or treated while seated Systolic Blood pressure >150and/or Diastolic Blood pressure >100 - Taking hypertensive medications of HCTZ or ACE/ARB - Allergy to HCTZ, heparin, nitroglycerin or lidocaine - History of allergy or unacceptable side effects from ACE inhibitors - Pregnancy or intent to become pregnant during the study - Smoking - Subject unable to give voluntary informed consent Physical Exam Exclusion Criteria - Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) from history or ECG in subjects > 40 years old - Pneumonia - Hepatic Failure/Jaundice - Renal Failure - Acute Cerebrovascular/ Neurological deficit - Fever greater than 38.0 C Screening Laboratory Tests Exclusion Criteria according to protocol


NCT ID:

NCT00574834


Primary Contact:

Principal Investigator
Stephen N. Davis, MD, FRCP
University of Maryland


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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