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Metabolic Syndrome X clinical trials

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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: 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: NCT03306771 Not yet recruiting - Metabolic Syndrome Clinical Trials

The Relationship Between Morbid Obesity and Carotid Artery Stenosis

Start date: June 2018
Phase: N/A
Study type: Observational

The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.

NCT ID: NCT03222167 Not yet recruiting - Metabolic Syndrome Clinical Trials

Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b

Start date: October 2017
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-label trial of Elbasvir/ Grazoprevir 50/100 mg fixed dose combination 12 week treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with of metabolic syndrome. The study to be conducted in conformance with Good Clinical Practices. A total of 60 subjects will be studied at 2 sites in the Republic of Kazakhstan. Males and Females treatment naïve patients with CHC genotype 1b infection associated with metabolic syndrome (MS), 18-70 years of age, with or without severe fibrosis / compensated cirrhosis will be enrolled. SVR 12 (primary endpoint) will be evaluated. Patients will be stratified by fibrosis stage and presence of metabolic syndrome components. Interim Analysis will be performed in order to estimate viral kinetics, applicability of SVR4 and durability of SVR12 by evaluation of virologic response at week 4 and 8 of treatment and follow-up at week 4 (SVR 4) and 24 will be performed - this will be a descriptive summary only without hypothesis testing. The main hypothesis is that 12-week therapy with MK-5172 in combination with MK-8742 for treatment-naïve patients with HCV genotype 1b with metabolic syndrome is not notably worse than the same course for treatment-naïve patients with HCV genotype 1b without metabolic syndrome.

NCT ID: NCT03058016 Not yet recruiting - Metabolic Syndrome Clinical Trials

Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This clinical study is designed to evaluate the providing of a computational prediction engine for optimization of personalized nutrition Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.

NCT ID: NCT03009279 Not yet recruiting - Metabolic Syndrome Clinical Trials

Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)

Start date: January 2017
Phase: N/A
Study type: Observational

To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).

NCT ID: NCT03006289 Not yet recruiting - Thyroid Cancer Clinical Trials

Relationship of Metabolic Syndrome and Its Components With Thyroid Cancer

Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the association between metabolic syndrome (MS), body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen for the risk factors that affect the incidence of thyroid cancer.

NCT ID: NCT02610322 Not yet recruiting - Metabolic Syndrome Clinical Trials

Whole Soy Replacement Diet on Metabolic Features

Start date: June 2016
Phase: N/A
Study type: Interventional

Project title: A randomized controlled trial of whole soy diet in place of red/processed meat and high fat dairy products on metabolic features in postmenopausal women Objectives: Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to examine the effect of whole soy replacement diet on the features of MetS among postmenopausal women. Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy products will significantly improve metabolic features. Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among 208 postmenopausal women with high risk of MetS or early MetS. Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either of two intervention groups, whole soy replacement group or control group, each for 6 months. Interventions: Subjects in whole soy group will be required to include 4 servings of whole soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or processed meat and high fat dairy products. Subjects in the control group will remain an usual diet. Main outcome measures: The outcome measures will include the indices of metabolic features as well as a 10-year risk for ischemic cardiovascular disease. Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be compared among the two groups. Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich animal products will notably decrease the risk of MetS.

NCT ID: NCT02606812 Not yet recruiting - Clinical trials for Metabolic Syndrome X

Effect of Food Consumption on microRNA Related to Metabolic Syndrome

EFCMRNAMS
Start date: March 2017
Phase: N/A
Study type: Interventional

The objective of the Project is to assess the effect of traditional food on the expression of micro-ribonucleic acid (miRNA), which regulate genes related to glucose metabolism. It will be a randomized experimental research. The research hypothesis is that consumption of traditional food will resolve biomarkers of glucose-related anomalies. Students of The Academic Division of Health Sciences (DACS for its initials in Spanish) will be invited to participate and they will be divided randomly in two groups. The experimental group will receive daily, five days per week, during three months, a lunch based on traditional Mesoamerican food emphasizing local produce. The experimental group will be provided an equivalent ratio of fast food from the school cafeterias. In both groups, at the start and end of the protocol, values of lipid, glucose, reactive protein C, alanine aminotransferase, and glycosylated hemoglobin profiles will be determined through spectrophotometric methods. The levels of expression of five miARN involved in regulating genes related to glucose metabolism (miR-320, miR-33a/b, miR-145, miR-335, and miR-124a) will be determined also by means of PCR amplification techniques. Statistical analyses will be based on two-way ANOVA, with a Dunnet's test procedure to find significance in measurements; significance will be set at p ≤ 0.05.

NCT ID: NCT02525276 Not yet recruiting - Metabolic Syndrome Clinical Trials

Female Sex Hormones, Insulin Resistance and Effects of Exercise in a Human Experimental Model of Menopause

Start date: August 2015
Phase: N/A
Study type: Interventional

The main objective of this study is to investigate the role of female sex hormones in relation to insulin resistance in a controlled human experimental model of menopause and to explore whether exercise and/or hormone treatment (HT) can compensate for loss of endogenous sex hormone production by maintaining insulin sensitivity and metabolic activity at a level equivalent to what is seen in premenopausal women. Loss of ovarian function is associated with an increased incidence of metabolic disease including metabolic syndrome, type 2 diabetes and cardiovascular disease. This increased disease incidence seems to be related to changes in body composition including decreased skeletal muscle mass and increased visceral fat mass as well as decreased whole body fat oxidation and energy expenditure. Regular physical activity decreases general mortality among other things by increasing fat free mass and insulin sensitivity and hereby prevents metabolic syndrome and cardiovascular disease - conditions seen with an increased incidence after menopause and could therefore be a possible treatment. In the present study the Investigators will assess the role of sex hormones in a model of menopause where healthy women are undergoing planned bilateral oophorectomy due to risk of hereditary ovary cancer. The use of this model makes it possible to control the time point for loss of ovarian function and hereby investigate the timeframe and possible contributing factors in a strictly controlled model. 48 premenopausal women will be included in the study. The study is conducted in women who have already been offered surgical oophorectomy. The first 2 months the study will be an observational cohort study. Hereafter the patients will be allocated to one of four groups (n=12) in a randomized controlled trial, addressing the effects of 6 months of exercise with or without HT. Type of surgery has been decided before inclusion based on medical indications. The women will be offered HT according to national guidelines, but the choice is up to them. Randomization applies only to the training intervention. Firstly the Investigators aim at investigating the role of endogenous female sex hormones and HT in relation to insulin resistance, whole body fat oxidation and -energy expenditure, changes in visceral fat mass and fat free mass after oophorectomy. Secondly, the Investigators wish to study the molecular mechanisms behind the oophorectomy-induced insulin resistance with a focus on insulin signaling in skeletal muscle and fat tissue. Lastly, the investigators aim to explore whether exercise and/or HT can compensate for loss of endogenous female sex hormone production by maintaining IS and metabolic activity, hereby preventing future incidents of metabolic disease in relation to menopause. All in all, this project will contribute with new knowledge concerning the question of how endogenous female sex hormones affect insulin sensitivity and metabolic functioning and how exercise may be used as a disease preventive modality for middle-aged women.