Phase 3 N=31 Randomized Quadruple-blind Treatment

Omega-3 Fatty Acids and Insulin Sensitivity

Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT01686568 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up — 10.92; 10.39; 10.16; 10.80 mg/kg FFM/min

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Omega-3 (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up	10.92; 10.39; 10.16; 10.80	—
SECONDARY Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up	537.17; 488.90; 561.33; 504.39	—
SECONDARY Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up	496.81; 564.86; 406.38; 495.12	—
SECONDARY Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)	22; 25; 18; 19	—
SECONDARY Senescent Cells	4; 4; 4; 4	—
SECONDARY Immunohistochemistry Assessments of Macrophage Burden	31; 33; 33; 31; 11; 13	—
SECONDARY Macrophage Crown-like Structures	0; 1; 0; 1	—

Summary

This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

Eligibility Criteria

Inclusion criteria

Age 18-65 years
Insulin resistant (Homeostasis Model Assessment (HOMA) Insulin Resistance (IR) ≥2.6)

Exclusion criteria

Current use of omega-3 nutritional supplements
Fasting plasma glucose ≥126 mg/dL
Active coronary artery disease
Participation in structured exercise (>2 times per week for 30 minutes or longer)
Smoking
Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
Renal failure (serum creatinine > 1.5mg/dl)
Chronic active liver disease (AST>144 IU/L and alanine transaminase (ALT)>165 IU/L)
Anti-coagulant therapy (warfarin/heparin)
International normalized ratio (INR) >3
Use of systemic glucocorticoids
Chronic use of NSAIDS or aspirin
Pregnancy or breastfeeding
Alcohol consumption greater than 2 glasses/day
Hypothyroidism
Fish or shellfish allergy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01686568). 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.