Status:
COMPLETED
Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Daiichi Sankyo
Conditions:
Impaired Glucose Tolerance
Prediabetic State
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers, β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD -...
Detailed Description
Diabetes is a common, major health problem in the United States, and it significantly increases the risk of developing heart disease, which is the leading cause of death. Research studies have shown t...
Eligibility Criteria
Inclusion
- Impaired glucose tolerance
Exclusion
- Diagnosis of diabetes
- Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
- Have systolic blood pressure \>140 mm Hg
- Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
- Vascular disease (cardiac, peripheral, cerebral)
- Renal insufficiency or hepatic abnormalities
- Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
- Anemia or a history of bleeding disorder
- Have a history of ARB or aspirin allergy
- Have the syndrome of asthma, rhinitis, and nasal polyps
- Have other medical problems which would preclude taking potential study medications for 12 months
- Are pregnant or have a positive pregnancy test
- Are breast feeding
- Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
- Have health status such that the envisioned blood sampling would confer a physiologic risk
- Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
- Do not appear capable of giving informed consent
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00122447
Start Date
May 1 2005
End Date
May 1 2011
Last Update
December 5 2013
Active Locations (2)
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1
Grady Health System
Atlanta, Georgia, United States, 30303
2
Emory University Hospital
Atlanta, Georgia, United States, 30322