Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Dec 13, 2007

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ClinConnect 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, th...

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Eligibility 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