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NCT ID: NCT03589690 Not yet recruiting - Metabolic Syndrome Clinical Trials

Alpha Lipoic Acid Supplementation and Metabolic Syndrome

Start date: July 25, 2018
Phase: N/A
Study type: Interventional

Metabolic syndrome is a collection of metabolic disorders. Abdominal obesity, dyslipidemia, reduced levels of high-density lipoprotein cholesterol, increased levels of serum triglyceride, insulin resistance are among the risk factors for metabolic syndrome and it has a global prevalence of 10 - 50 %. Alpha-lipoic acid or thioctic acid is an antioxidant that may have effects on inflammatory pathways, glucose control indicators, blood pressure, lipid profiles, body weight, fat mass, and food intake regulation. This study will be conducted as a parallel randomized double-blind clinical trial. In this study, 44 patients will be enrolled from endocrine and metabolism center of Shariati Hospital where their metabolic syndrome was diagnosed by an endocrinologist. At the beginning of the study written a self -administration will be taken from all patients. In this study, patient will be randomly divided into two groups, each will be received supplement or placebo for 12 weeks. 22 of patients will be consume 600 mg Alpha lipoic acid for 12 weeks and 22 of patients will be consume 600 mg placebo (starch-filled) capsules daily. Both supplementation and placebo are provided from "Sepehr Drug and Treatment" company. Before the study, containers will be coded as A and B by a person other than the study researchers according to concealment rules. Physical activity information will be collected using short-IPAQ (International Physical Activity Questionnaire) and demographic information through a general information questionnaire. In order to evaluate dietary intake of patients in terms of energy(kcal/(day), carbohydrate(gr/day), protein(gr/day), fat intake(gr/day), SFA (Saturated fatty acids) (gr/day), MUFA (Monounsaturated fatty acids) (gr/day), PUFA (Polyunsaturated fatty acids)(gr/day), Vitamin E(mg/day), Vitamin C(mg/day), Beta-carotene(mg/day) and Sodium intake (mg/day), 24-hr recalls will be completed by interviewing the patient for 3 days (two normal days and a weekend day). Weight will be measured with the minimum dress and without shoes by using a digital balance scale of 100 grams and height will be measured without shoes by meters mounted to the wall with an accuracy of 0.1 centimeters. Then the body mass index will be calculated by dividing the weight (kg) by the square of the height (m), waist circumference will be measured in the narrowest area between the lowest lumbar spine and the iliac bone (cm), systolic and diastolic blood pressure will be measured after 15 minutes of rest, twice using the mercuric barometric measure and the mean will be reported as individual blood pressure. The blood sample will be taken after 12 hours of overnight fasting in two groups for measuring fasting blood glucose(mg/dL), lipid profile(mg/dL), glycosylated hemoglobin(percentage), serum insulin concentration (uIU/ml) ,TAC (Total antioxidant capacity) (umol/L), CRP (C-reactive protein) (ng/ml) and TNF-a (Tumor necrosis factor-a ) (pg/ml)and will be used the HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) formula to determine insulin resistance. All these steps will be completed at the start and end of the study. At the end of the study, counting the remaining capsules, the patient's compliance rate will be evaluated, and patients who have not consumed less than 90% of their capsules will be excluded from the analysis.

NCT ID: NCT03585946 Not yet recruiting - Clinical trials for Stevens-Johnson Syndrome

Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Start date: January 1, 2024
Phase:
Study type: Observational

This is a prospective, multicenter cohort observational; study to compare treatment outcomes in patients admitted to the hospital with Stevens-Johnsons Syndrome/Toxic Epidermolysis, aiming to assess the utility of medical management. The hypothesis of this study is that one or more treatment options will demonstrate improved patient outcomes. The primary objectives are cessation of progression of disease, time to complete re-epithelialization, length of stay, and mortality rate in the treatment groups as compared to those receiving supportive care alone. Exploratory analyses will assess the cause, risk factors, and severity prediction factors associated with the disease.

NCT ID: NCT03585738 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

IPOSI-1
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS. Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited. Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in Assisted Reproductive Technology (ART) in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies. Furthermore, independently by the effect on PCOS related infertility, few data are available about the role of inositol on obstetrics outcomes of pregnancies conceived after treatment with inositol and/or orally supplemented during pregnancy. Considering that the combination of MI and DCI alleviate many of the metabolic dysregulations typical of PCOS thanks to insulin-sensitizing actions, it is plausible consider a beneficial effects on pregnancy complications such as gestational diabetes and preeclampsia.

NCT ID: NCT03575182 Not yet recruiting - Clinical trials for Ehlers-Danlos Syndrome

Gait Retraining in Patients With Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of gait retraining with biofeedback in the treatment of neuromusculoskeletal symptoms in patients with Joint Hypermobility Syndrome/Hypermobile Ehlers Danlos Syndrome. Half of participants will participate in a gait retraining program, while the other half will continue standard care.

NCT ID: NCT03572881 Not yet recruiting - Clinical trials for Brugada Syndrome Type 1

Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping

SB-CARTO
Start date: July 2018
Phase: N/A
Study type: Interventional

Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome. Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG. The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.

NCT ID: NCT03571178 Not yet recruiting - Clinical trials for Myofascial Pain Syndrome

Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome

Start date: August 2018
Phase: N/A
Study type: Interventional

The myofascial points within the trapezius muscle are hypoechogenic regions that can be depicted via ultrasound imaging. In this study we aimed to demonstrate the hypoechogenic regions within the trapezius muscle and to determine if physical therapy modalities change the appearance and size of these areas. We also wanted to explore if the presence of these areas correlate with pain.

NCT ID: NCT03540810 Not yet recruiting - Clinical trials for Primary Antiphospholipid Syndrome

Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome

PAPIRUS
Start date: August 15, 2018
Phase: Phase 3
Study type: Interventional

Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or obstetrical manifestations, along with biological anomalies related to the presence of antiphospholipid antibodies. Despite actual treatment recommended by international guidelines, the relapse rate in APS is high and survival is 65% at 15 years. Hydroxychloroquine has demonstrated its efficacy and benefits in the treatment of Systemic Lupus Erythematosus, but there is no current consensus concerning the efficacy of this treatment in the secondary prevention of thrombotic events in primary APS, even though several in vitro experimental and animal model data, along with several clinical studies have suggested a beneficial effect of this drug in this indication. Considering the prevalence of primary APS in the general population and of the number of clinical events observed in patients with primary APS and receiving conventional treatment with vitamin K anticoagulants (VKA), the consortium expects a minimum clinically relevant difference of 70%. Considering a prevalence of thrombotic events for the entire studied primary APS population of 10% at 2 years, the consortium expects a 70% decrease in thrombotic events under Hydroxychloroquine treatment administered in addition to VKA treatment in primary APS, i.e. a 3% prevalence in the Hydroxychloroquine group at 2 years. The consortium proposes a drug trial, phase III, national multicentric, comparative, randomized, superiority, double-blind, controlled with 2 compared groups (Hydroxychloroquine versus placebo) study. The enrolment period will be 24 months. The main aim of this trial is to comparatively assess at 24 months the number of new thrombotic events (venous and arterial) in primary antiphospholipid syndrome in patients treated with VKA plus Hydroxychloroquine versus VKA plus placebo, in a multicentre, prospective randomized, double-blind, versus placebo study.

NCT ID: NCT03469115 Not yet recruiting - Metabolic Syndrome Clinical Trials

New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin

Start date: March 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.

NCT ID: NCT03468491 Not yet recruiting - Clinical trials for Patellofemoral Pain Syndrome

The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

Start date: June 20, 2018
Phase: N/A
Study type: Interventional

The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus

NCT ID: NCT03384485 Not yet recruiting - Clinical trials for Antiphospholipid Syndrome

Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients With Antiphospholipid Syndrome.

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Fabry disease, an X-linked disorder of glycosphingolipids that is caused by mutations of the GLA gene that codes for α-galactosidase A, leads to dysfunction of many cell types and includes a systemic vasculopathy. As a result, patients have a markedly increased risk of developing ischemic stroke, small-fiber peripheral neuropathy, cardiac dysfunction and chronic kidney disease. Because this disease is a rare disease most of the time it is misdiagnosed, so in this study we will check out the Prevalence of lysosomal hydrolase alpha-glagtosidase deficiency ( Fabry disease) in patients with Antiphospholipid Syndrome.