Trial Outcomes & Findings for Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes (NCT NCT00738023)

NCT ID: NCT00738023

Last Updated: 2014-12-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: Baseline, 48 hours
• Results posted on: 2014-12-30

Participant Flow

Four subjects were withdrawn due to exclusion criteria prior to randomization. Non-diabetic arm did not continue after the first intralipid infusion (period 1).

Participant milestones

Measure	Diabetics Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
Intralipid Infusion STARTED	19	13
Intralipid Infusion COMPLETED	19	13
Intralipid Infusion NOT COMPLETED	0	0
Saline Infusion STARTED	19	0
Saline Infusion COMPLETED	19	0
Saline Infusion NOT COMPLETED	0	0
Intralipid Infusion (Post 6 Wks of Drug) STARTED	19	0
Intralipid Infusion (Post 6 Wks of Drug) COMPLETED	19	0
Intralipid Infusion (Post 6 Wks of Drug) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Diabetics n=19 Participants Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic n=13 Participants Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours	Total n=32 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 2 • n=5 Participants	42 years STANDARD_DEVIATION 1 • n=7 Participants	41.5 years STANDARD_DEVIATION 0.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 48 hours

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

Outcome measures

Measure	Diabetics n=19 Participants Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic n=13 Participants Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
Changes in Systolic Blood Pressure During Initial Intralipid Infusion	23 mmHg Standard Error 9	13 mmHg Standard Error 12

SECONDARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Diabetics n=19 Participants Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
Changes in Systolic Blood Pressure During Saline Infusions	0 mmHg Standard Error 4	—

SECONDARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Diabetics n=19 Participants Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention	1 mmHg Standard Error 6	—

Adverse Events

Diabetics

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Non-Diabetic

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diabetics n=19 participants at risk Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours	Non-Diabetic n=13 participants at risk Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
Vascular disorders pain at IV site	10.5% 2/19 • Number of events 2	7.7% 1/13 • Number of events 1

Additional Information

Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place