Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
• Treatments: Hydrochlorothiazide; Ramipril

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