Trial Outcomes & Findings for Free Fatty Acids and Vascular Function in Subjects With Diabetes (NCT NCT00153179)

Results Overview

Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

7 days

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls, Placebo First, Then Acipimox The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Healthy Controls, Acipimox First, Then Placebo The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Metabolic Syndrome, Placebo First, Then Acipimox The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Metabolic Syndrome, Acipimox First, Then Placebo The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
Study Visit Day 1 STARTED	10	8	13	9
Study Visit Day 1 COMPLETED	10	8	13	9
Study Visit Day 1 NOT COMPLETED	0	0	0	0
Study Visit Day 2 STARTED	10	8	13	9
Study Visit Day 2 COMPLETED	9	8	11	7
Study Visit Day 2 NOT COMPLETED	1	0	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Controls, Placebo First, Then Acipimox The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Healthy Controls, Acipimox First, Then Placebo The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Metabolic Syndrome, Placebo First, Then Acipimox The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.	Metabolic Syndrome, Acipimox First, Then Placebo The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
Study Visit Day 2 Withdrawal by Subject	1	0	2	2

Baseline Characteristics

Free Fatty Acids and Vascular Function in Subjects With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=18 Participants	Metabolic Syndrome n=22 Participants	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.1 years STANDARD_DEVIATION 5.6 • n=5 Participants	58.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	55.6 years STANDARD_DEVIATION 8.05 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.

Outcome measures

Outcome measures
Measure	Healthy Controls, Placebo Treatment n=17 Participants	Healthy Controls, Acipimox Treatment n=17 Participants	Metabolic Syndrome, Placebo Treatment n=18 Participants	Metabolic Syndrome, Acipimox Treatment n=18 Participants
Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome	10.65 Flow mediated dilation Standard Deviation 4.73	11.57 Flow mediated dilation Standard Deviation 5.72	8.79 Flow mediated dilation Standard Deviation 6.90	9.52 Flow mediated dilation Standard Deviation 6.38

PRIMARY outcome

Timeframe: baseline, 7 days

Population: The data for this outcome measure was lost when the investigator left the institution, so the measure was not analyzed.

Insulin sensitivity (M) is measured by using a hyperinsulinaemic-euglycaemic clamp. Insulin sensitivity (M) was calculated as the average glucose infusion rate (mg/kg of body weight per min) over the last 30 min of the clamp. Higher values indicate better outcomes (more insulin sensitive), while lower values indicate more insulin resistance.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metabolic Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark A. Creager

Brigham and Women's Hospital

Phone: 603-650-8283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place