Omega-3 Fatty Acids and Insulin Sensitivity

NCT01686568 | Completed Phase 3 Results FDA Drug

• 7 other identifiers: 12-004590KL2TR000136U24DK100469DK50456DK404845T32DK0073525UL1TR000135
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up

  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.

  Baseline, after 6 months of treatment

Secondary Outcomes (6)

• Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up

  baseline, after 6 months of treatment

• Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up

  Baseline, after 6 months of treatment

• Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)

  approximately after 6 months of treatment

• Senescent Cells

  approximately after 6 months of treatment

• Immunohistochemistry Assessments of Macrophage Burden

  approximately after 6 months of treatment

Study Arms (2)

Omega-3

EXPERIMENTAL

Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.

Drug: Omega-3

Placebo

PLACEBO COMPARATOR

Patients in this group will be supplemented with placebo capsules containing ethyl oleate.

Drug: placebo

Interventions

Omega-3 DRUG

Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.

Also known as: Essential fatty acids, Omega-3 fatty acids, Omega-3 polyunsaturated fatty acids, PUFAs, Lovaza

Omega-3

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Building Interdisciplinary Research Careers in Women's Health: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Lalia AZ, Johnson ML, Jensen MD, Hames KC, Port JD, Lanza IR. Effects of Dietary n-3 Fatty Acids on Hepatic and Peripheral Insulin Sensitivity in Insulin-Resistant Humans. Diabetes Care. 2015 Jul;38(7):1228-37. doi: 10.2337/dc14-3101. Epub 2015 Apr 7.

  PMID: 25852206 RESULT

• Hames KC, Morgan-Bathke M, Harteneck DA, Zhou L, Port JD, Lanza IR, Jensen MD. Very-long-chain omega-3 fatty acid supplements and adipose tissue functions: a randomized controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1552-1558. doi: 10.3945/ajcn.116.148114. Epub 2017 Apr 19.

  PMID: 28424185 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Docosahexaenoic Acids; Fatty Acids, Essential; Fatty Acids, Omega-3; Omacor

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Ian R. Lanza
• Organization: Mayo Clinic

lanza.ian@mayo.edu

507-255-8147

Study Officials

• Ian Lanza, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 18, 2012
• Study Start: December 21, 2012
• Primary Completion: October 30, 2014
• Study Completion: June 8, 2015
• Last Updated: March 3, 2017
• Results First Posted: July 10, 2015

Record last verified: 2017-01

Locations

US (1)