CompletedNCT00738023Updated Dec 30, 2014Results posted

Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes

A Phase 4 interventional study of Rosiglitazone and Normal saline 0.9% in Type 2 Diabetes and Hypertension, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 resistance and metabolic syndrome. The effect of FFA on insulin action is well established (4-6); however, the pressor effect of FFA infusion in obese subjects has not been investigated. We hypothesize that observed changes in blood pressure is the result of acute endothelial dysfunction due to increased FFA concentration; and that rosiglitazone, a PPAR gamma receptor agonist, will protect against FFA-induced elevation in blood pressure and endothelial dysfunction in obese subjects.

Conditions studied

Type 2 Diabetes
Hypertension

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Keywords

diabetes,
hypertension,
free-fatty acids

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 36 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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 \< 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 criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 36 participants (actual)

Study arms

Active comparator
Diabetics
Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
Drug: Rosiglitazone · Drug: Normal saline 0.9% · Drug: Intralipid 20%
Active comparator
Non-Diabetic
Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
Drug: Intralipid 20%

Interventions

DrugRosiglitazone
Diabetic subjects will be receive rosiglitazone for 6 weeks
DrugNormal saline 0.9%
Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours
DrugIntralipid 20%
Intralipid 20% at 40ml/hr intravenously for 48 hours

What researchers measure

Primary outcomes

Changes in Systolic Blood Pressure During Initial Intralipid Infusion
Systolic blood pressure change from baseline during an 48-hour intralipid infusion
Time frame: Baseline, 48 hours

Secondary outcomes

Changes in Systolic Blood Pressure During Saline Infusions
Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects
Time frame: 48 hours
Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention
Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects
Time frame: 48 hours

Results

Posted Dec 30, 2014

Participant flow

Intralipid Infusion

Participant flow — Intralipid Infusion
Milestone	Diabetics	Non-Diabetic
Started	19	13
Completed	19	13
Not completed	0	0

Saline Infusion

Participant flow — Saline Infusion
Milestone	Diabetics	Non-Diabetic
Started	19	0
Completed	19	0
Not completed	0	0

Intralipid Infusion (Post 6 Wks of Drug)

Participant flow — Intralipid Infusion (Post 6 Wks of Drug)
Milestone	Diabetics	Non-Diabetic
Started	19	0
Completed	19	0
Not completed	0	0

Outcome measures

PrimaryChanges in Systolic Blood Pressure During Initial Intralipid Infusion

Systolic blood pressure change from baseline during an 48-hour intralipid infusion

Time frame:: Baseline, 48 hours
Reported as:: Mean · mmHg

Changes in Systolic Blood Pressure During Initial Intralipid Infusion
mmHg	Diabetics	Non-Diabetic
Changes in Systolic Blood Pressure During Initial Intralipid Infusion	23 ± 9	13 ± 12

SecondaryChanges in Systolic Blood Pressure During Saline Infusions

Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects

Time frame:: 48 hours
Reported as:: Mean · mmHg

Changes in Systolic Blood Pressure During Saline Infusions
mmHg	Diabetics
Changes in Systolic Blood Pressure During Saline Infusions	0 ± 4

SecondaryChanges in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention

Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects

Time frame:: 48 hours
Reported as:: Mean · mmHg

Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention
mmHg	Diabetics
Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention	1 ± 6

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Diabetics	—	0/19 (0%)	2/19 (10.5%)
Non-Diabetic	—	0/13 (0%)	1/13 (7.7%)

Most frequent other events

Most frequent other events
Event	Diabetics	Non-Diabetic
pain at IV siteVascular disorders	2/19	1/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Diabetics	Non-Diabetic	Total
Mean	41 ± 2	42 ± 1	41.5 ± 0.7

Sex: Female, Male
Sex: Female, Male(Participants)	Diabetics	Non-Diabetic	Total
Female	7	9	16
Male	12	4	16

Study locations

1 site

Grady Memorial Hospital
Atlanta, Georgia 30303, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00738023
Lead sponsor: Emory University
Collaborators: GlaxoSmithKline
Responsible party: Guillermo Umpierrez (Professor, Emory University) — Principal investigator
First posted: Aug 20, 2008
Start date: Mar 2004
Primary completion: Dec 2009
Completion: Dec 2009
Results posted: Dec 30, 2014
Last update: Dec 30, 2014

Study contacts

Guillermo Umpierrez, MD

principal investigator · Emory University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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