NCT00759291

Brief Summary

This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

11.7 years

First QC Date

September 24, 2008

Results QC Date

May 10, 2021

Last Update Submit

February 17, 2023

Conditions

Metabolic Syndrome

Keywords

free fatty acidsinsulin-mediatedendothelium-dependent vasodilationmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Vasodilation

    Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period

    After 7 days of each treatment.

Study Arms (2)

Acipimox

ACTIVE COMPARATOR

Acipimox treatment QID for 7 days

Drug: acipimox

Placebo

PLACEBO COMPARATOR

Placebo treatment QID for 7 days

Drug: Placebo

Interventions

acipimoxDRUG

250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

Also known as: Olbetam
Acipimox
PlaceboDRUG

1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
  • abdominal obesity
  • elevated fasting blood sugar (110 mg/dL\< glucose \< 126 mg/dL)
  • low HDL
  • elevated fasting blood triglycerides (\> 150 mg/dL)
  • hypertension (BP \> 140/90 mm HG)
  • Normal cardiovascular examination

You may not qualify if:

  • Diabetes mellitus
  • Untreated hypercholesterolemia (LDL \> 75th percentile for age)
  • Cigarette smoking within 1 year
  • Renal insufficiency (creatinine \> 1.4 mg/dl)
  • Blood dyscrasia
  • Hepatic dysfunction (ALT \> 2x normal)
  • Evident coronary/peripheral atherosclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1.

    PMID: 31571412RESULT

  • Sullivan AE, Courvan MCS, Ada AW, Wasserman DH, Niswender KD, Shardelow EM, Wells EK, Wells QS, Freiberg MS, Beckman JA. The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70031. doi: 10.1002/edm2.70031.

    PMID: 39888728DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

acipimox

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Joshua Beckman
Organization
UT Southwestern
joshua.beckman@utsouthwestern.edu
214-648-3100

Study Officials

  • Joshua A. Beckman, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

April 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 30, 2017

Last Updated

February 21, 2023

Results First Posted

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)