Phase 2 N=40 Randomized Quadruple-blind Treatment

Free Fatty Acids and Vascular Function in Subjects With Diabetes

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00153179 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome — 10.65; 11.57; 8.79; 9.52 Flow mediated dilation

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: acipimox (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome	10.65; 11.57; 8.79; 9.52	—
PRIMARY Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo	—	—

Summary

This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.

Eligibility Criteria

Inclusion Criteria

type 2 diabetes mellitus (as defined by the National Diabetes Data Group)
normal cardiovascular exam
non smoker (for 1 year prior to entry)
Healthy volunteers
no known medical problems
normal cardiovascular exam
fasting glucose 140/90 mmHg)
untreated hypercholesterolemia (LDL > 75th percentile for age)
cigarette smoking within 1 year
neuropathy requiring medication
nephropathy (> 300mg/24 hour urinary albumin, or serum creatinine > 1.4 mg/dL
abnormal cardiovascular exam
treatment with thiazolidinedione within 1 year
post-menopausal women taking hormone replacement therapy

(Note: subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) must stop these medications for 2 weeks prior to taking study drug. If blood pressure rises to >140/90, subjects will be prescribed an alternative medication or be withdrawn from the study.

Healthy Volunteers

abnormal cardiovascular exam
use of prescription medications
fasting glucose > 110mg/dL
cigarette smoking within 1 year

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00153179). 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.