Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes (NCT00574834) | Clinical Trial Compass
TerminatedEarly Phase 1
Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Stopped: Lack of funding
United States17 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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