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Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

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ClinicalTrials.gov Identifier: NCT03615534
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : October 12, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Al-Kindy College of Medicine
Information provided by (Responsible Party):
Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine

Brief Summary:

Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations.

Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established.

The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.


Condition or disease Intervention/treatment Phase
Atherogenic Dyslipidemia Obesity Associated Disorder Other: Therapeutic Lifestyle Changes Other: Placebo Drug: Fenofibrate Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : October 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
Other: Therapeutic Lifestyle Changes
Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Other: Placebo
Active Comparator: Fenofibrate Monotherapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
Other: Therapeutic Lifestyle Changes
Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Drug: Fenofibrate
Other Name: Lipanthyl

Active Comparator: WMER Niacin Monotherapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Other: Therapeutic Lifestyle Changes
Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)
Other Name: ENDUR-ACIN®

Active Comparator: Combination Therapy
Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
Other: Therapeutic Lifestyle Changes
Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Drug: Fenofibrate
Other Name: Lipanthyl

Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)
Other Name: ENDUR-ACIN®




Primary Outcome Measures :
  1. Changes Serum Triglyceride Levels [ Time Frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments. ]
    Assessments involve the measurement of serum Triglyceride (TG) level.

  2. Changes in Serum Lipoprotein Cholesterol Levels [ Time Frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments. ]

    Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels.

    Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.


  3. Changes in Serum Apolipoprotein Levels [ Time Frame: Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments. ]
    Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.


Secondary Outcome Measures :
  1. Changes in Serum Fasting Glucose Levels. [ Time Frame: Changes from baseline were assessed at the end eighth week of treatments. ]
    Assessments involve the measurement of serum fasting glucose levels.

  2. Changes in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Changes from baseline were assessed at the end of the eighth week of treatments. ]
    Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .

  3. Changes in Serum Uric Acid Levels [ Time Frame: Changes from baseline were assessed at the end of the eighth week of treatments. ]
    Assessments involve the measurement of serum uric acid levels

  4. Changes in Serum Enzymes Levels [ Time Frame: Changes from baseline were assessed at the end of the eighth week of treatments. ]
    Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.

  5. Changes in Systolic and Diastolic Blood Pressure [ Time Frame: Changes from baseline were assessed at the end of the eighth week of treatments. ]
    Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.

  6. Adverse Events [ Time Frame: Changes from baseline were assessed at the end of the eighth week of treatments. ]

    Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness.

    As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module.




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI≥30 kg/m2.
  • Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.

Exclusion Criteria:

  • The use of any antilipidemic medication.
  • Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).
  • Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).
  • Clinical or laboratory findings suggestive for thyroid dysfunction.
  • Established diagnosis of Diabetes Mellitus.
  • History of gout, hyperuricemia, or on hypouricemic agents.
  • Active peptic ulcer.
  • Pregnancy, or nursing mothers.
  • Alcohol or tobacco consumption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615534


Locations
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Iraq
Al Kindy College of Medicine, University of Baghdad
Baghdad, Iraq, 10045
Lewai S Abdulaziz
Baghdad, Iraq, 10045
Sponsors and Collaborators
Lewai Sharki Abdulaziz, MSc PhD
Al-Kindy College of Medicine
Investigators
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Study Chair: Lewai S Abdulaziz, MSc PhD Al-Kindy college of Medicine, University of Baghdad
Study Chair: May S Al-Sabbagh, MSc College of Pharmacy, University of Baghdad
Study Director: Marwah S Attar, MSc College of Pharmacy, University of Baghdad
Principal Investigator: Faris A Khazaal, FRCP Al-Kindy college of Medicine, University of Baghdad

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Responsible Party: Lewai Sharki Abdulaziz, MSc PhD, Assistant Professor, Al-Kindy College of Medicine
ClinicalTrials.gov Identifier: NCT03615534     History of Changes
Other Study ID Numbers: 1Al-KindyCM
First Posted: August 6, 2018    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (table, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 6 months and ending 24 months following article publication
Access Criteria: Anyone who wishes to access the data, to achieve aims in the approved proposal or for meta-analysis. The data will be available in our college's data warehouse up to 24 months following article publication.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine:
Extended Release Niacin
Fenofibrate
treatment
Obesity
Atherogenic Dyslipidemia

Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs