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Metabolic Syndrome | Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

Metabolic Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Metabolic Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:RamiprilRamipril 20 mg once daily for 6 months

Drug:HCTZ-hydrochlorothiazideHCTZ 25 mg once daily for 6 months

Drug:Ramipril+HCTZRamipril 20 mg and HCTZ 25 mg, both once daily for 6 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

RamiprilPatients randomized to 6 months treatment of Ramipril.

HCTZPAtients randomized to 6 months treatment of HCTZ.

Ramipril+HCTZPatients randomized to 6 months treatment of Ramipril+HCTZ.

Study Status

Terminated

Start Date: March 2007

Completed Date: August 2014

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Changes in Insulin Sensitivity

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Stephen N. Davis, MD, FRCP

Lead Sponsor: University of Maryland

Collaborator: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

More information:https://clinicaltrials.gov/show/NCT00574834

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