Expired Study
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Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

HP-00044872-Ramipril


NCT ID:

NCT00574834


Secondary ID:


Study Acronym:


Brief Title:

Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes


Official Title:

Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Maryland, Baltimore


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Lack of funding


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

17


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephen N. Davis, MD, FRCP
Principal Investigator
University of Maryland, Baltimore

Study Dates

Start Date:March 2007
Completion Date:August 2014
Completion Type:Actual
Primary Completion Date:August 2014
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 10, 2019
First Received Date:December 13, 2007
First Results Date:December 10, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Changes in Insulin Sensitivity
Time Frame:6 months
Safety Issues:False
Description:Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.

Study Interventions

Intervention Type:Drug
Name:Ramipril
Description:Ramipril 20 mg once daily for 6 months
Arm Name:Ramipril
Other Name:Altace
Intervention Type:Drug
Name:HCTZ-hydrochlorothiazide
Description:HCTZ 25 mg once daily for 6 months
Arm Name:HCTZ
Other Name:Brand Names: HydroDIURIL, Microzide
Intervention Type:Drug
Name:Ramipril+HCTZ
Description:Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
Arm Name:Ramipril+HCTZ
Other Name:Altace and HydroDIURIL, Microzide

Study Arms

Study Arm Type:Active Comparator
Arm Name:Ramipril+HCTZ
Description:Patients randomized to 6 months treatment of Ramipril+HCTZ.
Study Arm Type:Active Comparator
Arm Name:HCTZ
Description:PAtients randomized to 6 months treatment of HCTZ.
Study Arm Type:Active Comparator
Arm Name:Ramipril
Description:Patients randomized to 6 months treatment of Ramipril.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Maryland, Baltimore
Agency Class:Industry
Agency Type:Collaborator
Agency Name:King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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