View clinical trials related to Metabolic Syndrome X.
Filter by:Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Preliminary research has shown that the presence of certain trace elements may be associated with the development of CVD. This study will examine toenail clippings and laboratory data to evaluate the link between trace elements and CVD risk factors in young adults.
This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight individuals (n = 320) across Europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.
Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.
The secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria.
Investigating the effect of low dose growth hormone therapy on body fat composition, insulin sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low insulin-like growth factor (IGF-1) level.
The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. This study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.
- Aim 1: We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a 12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome (see Table 1). - Aim 2: In this secondary aim, we will test our hypothesis that the combination of niacin-ER and pioglitazone will significantly increase insulin sensitivity, when compared to niacin-ER alone, as measured by the frequently sampled intravenous glucose tolerance test (FSIGTT). - Aim 3: In this additional secondary aim, we will test our hypothesis that the combination of pioglitazone and niacin-ER will reduce markers of inflammation, including C-reactive protein (CRP), interleukin-6 (IL-6), soluble tumor necrosis factor alpha receptor type II (sTNF--R2), and resistin, and raise adiponectin when compared to niacin-ER alone. - Aim 4: In this exploratory aim, we will measure a broad spectrum of emerging cardiovascular risk factors in order to derive a richer sense of the effects of combination pioglitazone and niacin-ER in these individuals. We will collect adipose tissue level expression (mRNA & protein) relating to cholesterol transport (PPAR-, PPAR-, and PPAR-, ABCA1, ABCG1, and SR-B1), triglyceride transport/lipolysis (HM74a, HSL), adipocytokines (TNF-a, IL-6, adiponectin, leptin, acylation-stimulating protein), and glucose regulation (glut-4 and IRS-1). [assuming sufficient mRNA yield]. These findings will serve as hypothesis-generating data for future studies..
Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: - To assess the effect of rimonabant over a period of 12 months on: - Liver fat content using CT scan (Computed Tomography scan) - Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA)) - Lipid, lipoprotein profile - Glycemia, insulinemia and HbA1c - Adipokines, inflammatory and hemostatic markers - To evaluate the percentage of patients with metabolic syndrome at 12 months - To evaluate the safety and tolerability of rimonabant in these patients In four selected US sites the effect of rimonabant at 12 months will be also assessed on: - Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp). - Resting metabolic rate and substrate oxidation at rest using indirect calorimetry. - Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
The risk of thrombotic complications after implantation of drug-eluting stents (DES) may be increased in patients with diabetes mellitus (DM) or metabolic syndrome (MS). It is recommended that all patients take an association of aspirin and clopidogrel for several months after DES implantation to reduce this risk. However, the biological efficacy of current antiplatelet therapies has not been studied prospectively and specifically in DM or MS patients. Our aim is to study the biological efficacy of an association of aspirin and clopidogrel (600 mg loading dose followed by 75 mg maintenance dose) using an assay measuring ex vivo shear-induced platelet aggregation (SIPA), along with other assays measuring platelet activation and aggregation, in patients with DM, MS, or no DM/MS. Patients with stable coronary artery disease and successful DES implantation in native coronary arteries will be eligible. They will be stratified at entry according to their metabolic status (DM, MS, or no DM/MS). Measurements will be performed 6-24 hours after clopidogrel loading dose (acute effects) and 4 months later under clopidogrel maintenance dose (chronic effects). Study end-points: A. Primary biological end-point: To compare SIPA levels in DM vs. MS vs. no DM/MS patients. B. Secondary biological end-points: - To compare the results of other tests of platelet aggregation/activation in DM vs. MS vs. no DM/MS patients. - To compare the acute (6-24 hours after clopidogrel loading dose) and chronic (4 months later) results of the above mentioned tests. These comparisons will be performed in the overall population and in each group (DM, MS, no DM/MS). C. Secondary clinical end-points: To study the relationship between SIPA levels (and the other tests of platelet aggregation/activation) and the occurrence of: - Periprocedural myocardial infarctions - Major adverse cardiac events (cardiovascular death, myocardial infarction or ischaemia-driven target vessel revascularization) at 4 and 12 months after stent implantation. We, the researchers at Assistance PUBLIQUE - HOPITAUX de Paris, anticipate our study may help improve our knowledge of the efficacy of current antiplatelet therapies in DM and MS patients treated with DES.