Try our beta test site

Omega-3 Fatty Acids and Insulin Sensitivity

This study has been completed.
National Center for Advancing Translational Science (NCATS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian R. Lanza, Mayo Clinic Identifier:
First received: September 11, 2012
Last updated: June 16, 2015
Last verified: June 2015
This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

Condition Intervention Phase
Insulin Resistance
Drug: Omega-3
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Omega-3 Fatty Acids as a Therapeutic Strategy in Insulin Resistant Humans

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up [ Time Frame: Baseline, after 6 months of treatment ]
    A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.

Secondary Outcome Measures:
  • Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up [ Time Frame: baseline, after 6 months of treatment ]
    Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.

  • Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up [ Time Frame: Baseline, after 6 months of treatment ]
    Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.

Enrollment: 31
Study Start Date: December 2012
Study Completion Date: June 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3
Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
Drug: Omega-3
Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
Other Names:
  • Essential fatty acids
  • Omega-3 fatty acids
  • Omega-3 polyunsaturated fatty acids
  • PUFAs
  • Lovaza
Placebo Comparator: Placebo
Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
Drug: placebo

Detailed Description:
Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. No existing studies have systematically evaluated the influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

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

Exclusion criteria:

  1. Current use of omega-3 nutritional supplements
  2. Fasting plasma glucose ≥126 mg/dL
  3. Active coronary artery disease
  4. Participation in structured exercise (>2 times per week for 30 minutes or longer)
  5. Smoking
  6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
  7. Renal failure (serum creatinine > 1.5mg/dl)
  8. Chronic active liver disease (AST>144 IU/L and alanine transaminase (ALT)>165 IU/L)
  9. Anti-coagulant therapy (warfarin/heparin)
  10. International normalized ratio (INR) >3
  11. Use of systemic glucocorticoids
  12. Chronic use of NSAIDS or aspirin
  13. Pregnancy or breastfeeding
  14. Alcohol consumption greater than 2 glasses/day
  15. Hypothyroidism
  16. Fish or shellfish allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01686568

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Center for Advancing Translational Science (NCATS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ian Lanza, PhD Mayo Clinic
  More Information

Responsible Party: Ian R. Lanza, Assistant Professor of Medicine, Mayo Clinic Identifier: NCT01686568     History of Changes
Other Study ID Numbers: 12-004590  KL2TR000136  U24DK100469  DK50456 
Study First Received: September 11, 2012
Results First Received: June 16, 2015
Last Updated: June 16, 2015

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on February 17, 2017