Niacin, N-3 Fatty Acids and Insulin Resistance

NCT00286234 | Completed Phase 4 Results DMC

• 2 other identifiers: DK61486 (completed)R01DK061486
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.

Conditions

Metabolic Syndrome; Hypertriglyceridemia

Keywords

triglycerides; HDL-cholesterol; insulin resistance; omega-3 fatty acids; niacin

Outcome Measures

Primary Outcomes (1)

• Serum TG

  Change From Baseline to 4 Months in Serum Triglycerides

  4 months

Secondary Outcomes (1)

• Non-HDL-C

  baseline and 4 months

Study Arms (4)

1

PLACEBO COMPARATOR

Dual placebo

Drug: placebo

2

EXPERIMENTAL

niaspan

Drug: extended release niacin

3

EXPERIMENTAL

lovaza

Drug: omega-3 acid ethyl esters

4

EXPERIMENTAL

combined therapy

Drug: combined treatment

Interventions

omega-3 acid ethyl esters DRUG

4 q qd

Also known as: lovaza omacor

3

extended release niacin DRUG

2 g qpm

Also known as: niaspan

2

placebo DRUG

omacor placebo plus niaspan placebo

1

combined treatment DRUG

omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm

Also known as: lovaza, omacor, niaspan

4

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and 69 years of age Male or female (without hormonal cycling as described below) BMI \> 25 Fasting serum triglycerides \> 150 mg/dL Ratio of TG/HDL-C \> 3.5

You may not qualify if:

• BMIs \> 40 kg/m2 TG \> 750 mg/dL HDL-C \< 10 mg/dL Presence of other secondary causes of dyslipidemia or hyperglycemia such as hepatic, renal, thyroid or other endocrine diseases History of hypersensitivity to niacin or fish oils History of gout, hepatitis, peptic ulcer or cardiovascular disease Presence of diabetes mellitus, whether controlled by diet or drugs. (We will eliminate subjects with undiagnosed diabetes by screening for fasting glucose \> 126 mg/dL) Use of any dietary supplements providing more than 50 mg of niacin or 100 mg of n-3 FA Use of any herbal preparations or weight-loss products Taking any lipid-lowering drugs for at least four weeks prior to screening for the study Medically-required treatment with nitrates, calcium channel blockers, or adrenergic blocking agents (per the Niaspan package insert) Hemoglobin \< 12 g/dL (owing to the significant amount of blood being drawn) LDL-C \> 145 mg/dL. (This restriction will prevent the randomization of any subject whose LDL-C levels, if assigned to an n-3 FA group, might rise by 10% and thus exceed 160 mg/dL) Known substance abuse Participation in a clinical drug trial anytime during the 30 days prior to screening Anyone whom the investigators judge to be a poor candidate

Sponsors & Collaborators

• University of South Dakota: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Sanford Clinic Clinical Research Services

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (3)

• Savinova OV, Fillaus K, Harris WS, Shearer GC. Effects of niacin and omega-3 fatty acids on the apolipoproteins in overweight patients with elevated triglycerides and reduced HDL cholesterol. Atherosclerosis. 2015 Jun;240(2):520-5. doi: 10.1016/j.atherosclerosis.2015.04.793. Epub 2015 Apr 22.

  PMID: 25932792 DERIVED

• Shearer GC, Pottala JV, Hansen SN, Brandenburg V, Harris WS. Effects of prescription niacin and omega-3 fatty acids on lipids and vascular function in metabolic syndrome: a randomized controlled trial. J Lipid Res. 2012 Nov;53(11):2429-35. doi: 10.1194/jlr.P022392. Epub 2012 Aug 14.

  PMID: 22892157 DERIVED

• Hu S, Shearer GC, Steffes MW, Harris WS, Bostom AG. Once-daily extended-release niacin lowers serum phosphorus concentrations in patients with metabolic syndrome dyslipidemia. Am J Kidney Dis. 2011 Jan;57(1):181-2. doi: 10.1053/j.ajkd.2010.06.029. Epub 2010 Oct 8. No abstract available.

  PMID: 20888102 DERIVED

Related Links

• Abstract to Published Paper

MeSH Terms

Conditions

Metabolic Syndrome; Hypertriglyceridemia; Insulin Resistance

Interventions

Omacor; Niacin; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Results Point of Contact

• Title: Dr. William Harris
• Organization: Sanford School of Medicine, University of South Dakota

bill@omegaquant.com

16052716917

Study Officials

• William S Harris, PhD

  Sanford Research/USD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Professor

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 3, 2006
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-09

Locations

US (1)