View Clinical Trial (Medical Research Study)
Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21201 |
| Conditions: |
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Metabolic Syndrome |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00574834 |
| Primary Contact: |
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Principal Investigator
Stephen N. Davis, MD, FRCP
University of Maryland, Baltimore County
Donna B. Tate
Phone: 410-706-5643
Email: dtate@medicine.umaryland.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21201
United States
Donna B. Tate
Phone: 410-706-5643
Email: dtate@medicine.umaryland.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
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