Metabolic Syndrome Clinical Trial
Official title:
Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia
The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.
Status | Terminated |
Enrollment | 12 |
Est. completion date | July 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male subjects or postmenopausal female subjects aged between 19-70 years - High risk patients (PROCAM risk =20%) on a stable statin-therapy, but at least simvastatin 20 mg/d - HDL-cholesterol =50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl - Lipoprotein (a) < 30 mg/dl - Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus. - Without niacin therapy for at least 6 months - Dosage of any concomitant medication has been stable for at least 3 weeks - If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml) Exclusion Criteria: - Subjects with additional causes for hyperlipoproteinemia - Diabetes mellitus or antidiabetic medication - Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina - History of psychiatric disorder or cognitive impairment that would interfere with participation in the study - History of alcoholism - Contraindication against niacin and/or laropiprant - Subject has participated in an investigational study within 30 days prior to study initiation - Fasting triglycerides >400 mg/dl - Life-threatening disease (e.g. cancer) - Renal insufficiency (GFR = 30 ml/min ) - Major hepatic impairment - Known allergic reaction/intolerance against niacin and/or laropiprant - Active peptic ulcer disease |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Klinik II, Klinikum der Universitaet Muenchen, Grosshadern | Munich |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | LDL-cholesterol | Percent change of LDL-cholesterol at 12 weeks compared to baseline | baseline and 12 weeks after treatment | No |
Primary | Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test | Percent change of incremental AUC at 12 weeks compared to baseline. | baseline and 12 weeks after treatment | No |
Secondary | HDL Cholesterol | Percent change of HDL-cholesterol at 12 weeks compared to baseline. | baseline and 12 weeks after treatment | No |
Secondary | Fasting Triglycerides | Percent change of fasting triglycerides at 12 weeks compared to baseline | baseline and 12 weeks after treatment | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04635202 -
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
|
N/A | |
Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
Completed |
NCT05343858 -
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Recruiting |
NCT05040958 -
Carotid Atherosclerotic Plaque Load and Neck Circumference
|
||
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Active, not recruiting |
NCT03613740 -
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
|
Phase 2 | |
Completed |
NCT04498455 -
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
|
Phase 4 | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Completed |
NCT03241121 -
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
|
N/A | |
Completed |
NCT04509206 -
Virtual Teaching Kitchen
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A |