Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

NCT00574834

Last updated date
Study Location
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metabolic Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-65 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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according to protocol

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Advanced Information
Descriptive Information
Brief Title  ICMJE Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Official Title  ICMJE Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Ramipril
    Ramipril 20 mg once daily for 6 months
    Other Name: Altace
  • Drug: HCTZ-hydrochlorothiazide
    HCTZ 25 mg once daily for 6 months
    Other Name: Brand Names: HydroDIURIL, Microzide
  • Drug: Ramipril+HCTZ
    Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months
    Other Name: Altace and HydroDIURIL, Microzide
Study Arms  ICMJE
  • Active Comparator: Ramipril
    Patients randomized to 6 months treatment of Ramipril.
    Intervention: Drug: Ramipril
  • Active Comparator: HCTZ
    PAtients randomized to 6 months treatment of HCTZ.
    Intervention: Drug: HCTZ-hydrochlorothiazide
  • Active Comparator: Ramipril+HCTZ
    Patients randomized to 6 months treatment of Ramipril+HCTZ.
    Intervention: Drug: Ramipril+HCTZ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
17
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
48
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574834
Other Study ID Numbers  ICMJE HP-00044872-Ramipril
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen N. Davis, MBBS, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Stephen N. Davis, MD, FRCPUniversity of Maryland, Baltimore
PRS Account University of Maryland, Baltimore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP