Status:
COMPLETED
Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Type 2 Diabetes
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hem...
Detailed Description
The FFA-induced hypertension constitutes a useful model with which to examine disease mechanisms and test new therapeutic interventions to correct the different disorders associated with insulin resis...
Eligibility Criteria
Inclusion
- Males or females between the ages of 18 and 70 years.
- Subjects must have a BMI of ≥ 30 kg/m2.
- Subjects must have a BP \< 130/80 mm Hg and no prior history of hypertension.
- A known history of type 2 diabetes mellitus \< 3 years (now 5 years).
- Subjects must have an HbA1c of \< 9%.
- Diabetic subjects must have been receiving as their only current anti-diabetic therapy stable doses of sulfonylureas for the last 2 months.
- Subjects must be able to understand and willing to adhere to the study protocol.
Exclusion
- Subjects with history of hypertension (BP \> 140/90 mm HG) or who have received antihypertensive drug therapy prior to the study.
- Obese nondiabetic controls with impaired glucose tolerance (2-hour glucose between 140 - 199 mg/dl) during a 75-g OGTT.
- Diabetic subjects who require insulin therapy or have received an insulin sensitizer agent (metformin, rosiglitazone, pioglitazone) within 3 months of entering the study (at SV1, week-2).
- Subjects with fasting triglyceride levels \> 250 mg/dL prior to the study (at SV1, week-2).
- Clinically relevant hepatic disease (ALT 2.5x \> upper limit of normal), or other significant medical or surgical illness.
- Renal failure, as shown by a serum creatinine ≥1.5 mg/dL for males, or ≥ 1.4 mg/dL for females.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00738023
Start Date
March 1 2004
End Date
December 1 2009
Last Update
December 30 2014
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303