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Omega-3 Fatty Acids and Insulin Sensitivity

This study is currently recruiting participants.
Verified April 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Ian R. Lanza, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01686568
First received: September 11, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change from baseline in insulin sensitivity by hyperinsulinemic-euglycemic clamp [ Time Frame: Baseline, after 6 months of treatment ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in beta cell function following ingestion of a mixed meal [ Time Frame: baseline, after 6 months of treatment ] [ Designated as safety issue: No ]
    Following consumption of a mixed meal, insulin secretion and beta cell function will be evaluated from serial measurements of C-peptide, insulin, and glucose.


Secondary Outcome Measures:
  • Change from baseline in mitochondrial function determined by muscle biopsy [ Time Frame: Baseline, after 6 months of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in muscle and liver lipid content [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    Magnetic resonance spectroscopy will be used to measure lipid content in skeletal muscle and liver.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age 18-65 years
  2. Insulin resistant (HOMA 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>144IU/L and ALT>165IU/L)
  9. Anti-coagulant therapy (warfarin/heparin)
  10. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686568

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ian R Lanza, PhD     507-255-8147     lanza.ian@Mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ian Lanza, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Ian R. Lanza, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01686568     History of Changes
Other Study ID Numbers: 12-004590
Study First Received: September 11, 2012
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013