Obesity Associated Disorder Clinical Trial
Official title:
Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
Verified date | January 2024 |
Source | Al-Kindy College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 161 |
Est. completion date | October 30, 2015 |
Est. primary completion date | June 30, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Iraq | Al Kindy College of Medicine, University of Baghdad | Baghdad | |
Iraq | Lewai S Abdulaziz | Baghdad |
Lead Sponsor | Collaborator |
---|---|
Lewai Sharki Abdulaziz, MSc PhD | Al-Kindy College of Medicine |
Iraq,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes Serum Triglyceride Levels | Assessments involve the measurement of serum Triglyceride (TG) level. | 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. | |
Primary | Changes in Serum Lipoprotein Cholesterol Levels | 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. |
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. | |
Primary | Changes in Serum Apolipoprotein Levels | Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels. | 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. | |
Secondary | Changes in Serum Fasting Glucose Levels. | Assessments involve the measurement of serum fasting glucose levels. | Changes from baseline were assessed at the end eighth week of treatments. | |
Secondary | Changes in Estimated Glomerular Filtration Rate (eGFR) | Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) . | Changes from baseline were assessed at the end of the eighth week of treatments. | |
Secondary | Changes in Serum Uric Acid Levels | Assessments involve the measurement of serum uric acid levels | Changes from baseline were assessed at the end of the eighth week of treatments. | |
Secondary | Changes in Serum Enzymes Levels | Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels. | Changes from baseline were assessed at the end of the eighth week of treatments. | |
Secondary | Changes in Systolic and Diastolic Blood Pressure | 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. | Changes from baseline were assessed at the end of the eighth week of treatments. | |
Secondary | Adverse Events | 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. |
Changes from baseline were assessed at the end of the eighth week of treatments. |
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