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Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

Information source: University of Maryland
Information obtained from ClinicalTrials.gov on December 08, 2011
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: University of Maryland

Official(s) and/or principal investigator(s):
Stephen N. Davis, MD, FRCP, Principal Investigator, Affiliation: University of Maryland

Overall contact:
Donna B. Tate, Phone: 410-706-5643, Email: dtate@medicine.umaryland.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 (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.

Clinical Details

Official title: Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Changes in 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, 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.

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Donna B. Tate, Phone: 410-706-5643, Email: dtate@medicine.umaryland.edu

University of Maryland, Baltimore, Baltimore, Maryland 21201, United States; Recruiting
Donna B. Tate, Phone: 410-706-5643, Email: dtate@medicine.umaryland.edu
Additional Information

Starting date: March 2007
Last updated: February 15, 2011

Page last updated: December 08, 2011

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