Phase 4
N=32
Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
Type 2 Diabetes · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00738023 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Changes in Systolic Blood Pressure During Initial Intralipid Infusion — 23; 13 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rosiglitazone (Drug); Normal saline 0.9% (Drug); Intralipid 20% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Systolic Blood Pressure During Initial Intralipid Infusion |
23; 13 | — |
| SECONDARY Changes in Systolic Blood Pressure During Saline Infusions |
— | — |
| SECONDARY Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention |
1 | — |
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 hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin to increase FFA ~ four-fold-baseline levels for 48 hours results in a significant and reproducible raise in systolic and diastolic blood pressure (BP) in obese African American subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known effect on insulin resistance, sustained elevation of FFA results in the development of an acute metabolic syndrome.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00738023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.