Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: Ramipril (Drug); HCTZ-hydrochlorothiazide (Drug); Ramipril+HCTZ (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Stephen N. Davis, MD, FRCP, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Vanessa J. Briscoe, PhD, ANP, Phone: 615-936-1824, Email: vanessa.j.briscoe@vanderbilt.edu
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 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.
Clinical Details
Official title: Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Primary outcome: Insulin Sensitivity
Detailed description:
Several studies have demonstrated that therapeutic agents used to reduce glucose levels
and/or weight can delay the onset of type 2 diabetes. Intriguingly, modulation of the
rennin-angiotensin-system by either 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 normo 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 48 (24 male / 24 female) with impaired glucose tolerance
- Fasting plasma glucose between 100 and 126 mg/dl or post prandial glucose between 140
and 200 mg/dl
- BMI greater than 25 kgM2
- Age: 20-65 years
Exclusion Criteria:
- Patients receiving agents that can increase or lower blood glucose, i. e., metformin,
thiazolidinediones, sulfonylureas, glitinides, acarbose, GLP-1 receptor agonists
- Current ACE or ARB therapy
- Pregnancy or intent to become pregnant during the study
- Smoking
Locations and Contacts
Vanessa J. Briscoe, PhD, ANP, Phone: 615-936-1824, Email: vanessa.j.briscoe@vanderbilt.edu
Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Vanessa J. Briscoe, PhD, ANP, Phone: 615-936-1824, Email: vanessa.j.briscoe@vanderbilt.edu
Additional Information
Starting date: March 2007
Ending date: December 2009
Last updated: June 23, 2009
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