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Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
NCT00738023Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2004
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules
- Drugs
- rosiglitazone
- Conditions
- hypertension (HTN)
01
Overview
Phase 4, randomised trial of rosiglitazone in hypertension (HTN) (2 arms), sponsored by Emory University. Primary endpoint: Changes in Systolic Blood Pressure During Initial Intralipid Infusion at 48 hours. Started Mar 2004; status: completed.
02
Design
2 arms- Study design
- Randomized
Diabetics
Obese, normotensive African-Americans with diabetes receiving sequential infusions and rosiglitazone treatment.
Non-Diabetic
Obese, normotensive African-Americans without diabetes receiving only the initial Intralipid infusion.
03
Who it enrols
Obese African American adults (18-70 years) with BMI >= 30, normal blood pressure (<130/80 mmHg), and either no diabetes or type 2 diabetes (<5 years) controlled only with sulfonylureas (HbA1c < 9%). Excludes those with prior hypertension, recent use of insulin or insulin sensitizers, high triglycerides, clinically relevant hepatic disease, renal failure, or pregnancy.
04
Endpoints
Primary
Changes in Systolic Blood Pressure During Initial Intralipid Infusion
Secondary
Changes in Systolic Blood Pressure During Saline Infusions
Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention
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