Status:
WITHDRAWN
Regression of Fatty Heart by Valsartan Therapy
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Metabolic Syndrome
Lipotoxicity
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Traditionally, obesity is considered an indirect cause of heart disease. Obese individuals typically present with a number of traditional Framingham risk factors (hypertension, dyslipidemia, and type ...
Detailed Description
Basic science in animal models of genetic obesity have demonstrated that obese, insulin resistant animals have fatty hearts with reduced functional ability. More importantly, insulin sensitizing treat...
Eligibility Criteria
Inclusion
- Prediabetic individuals with impaired glucose tolerance (2 hr postprandial glucose \> 140mg/dL) or having 3 of 5 Metabolic Syndrome criteria:
- Fasting glucose \> 100mg/dL;
- Waist circumference: men \> 102cm, women \> 88cm (confirmed with abdominal MRI);
- HDL: men \< 40mg/dL, women \< 50mg/dL;
- Triglycerides \> 150mg/dL;
- Blood pressure \> 130/80mmHg;
- Elevated hepatic triglycerides (\>5.5%) and myocardial triglycerides (\>0.6%)
- Elevated blood triglycerides \>150mg/dL
- Age \< 50 years
Exclusion
- Type 2 Diabetes mellitus
- Prior exposure to renin system blockers or HCTZ
- BP \> 160/100mmHg
- Claustrophobia
- Metallic implants in body
- Pregnant or planning to become pregnant
- Prior exposure to statin medications
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00745953
Start Date
August 1 2007
End Date
August 1 2009
Last Update
January 17 2019
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390