View clinical trials related to Metabolic Syndrome.
Filter by:An adaptation to a cold environment is a tendency to generate heat within our body. Some of this heat comes from our fat tissue. Although most fat tissue is "white fat", there are pockets deep within the body that are called "brown fat", which are specially adapted to burning fat and making heat. The investigator believes that our white fat, just underneath the surface of our skin, also has this property to burn fat and make heat, although not at the high level of brown fat. This study is to examine this fat-burning property of the white fat under the skin in response to seasons and to cold. Many such studies have been done in mice, but little has been done in humans. There are a number of factors, including age, weight, and medical history, that may make a person eligible or ineligible to participate in this study. Certain medications could make a person ineligible, but if these medications can be safely altered, the individual may become eligible.
Obesity represents one of the most important public health challenges for the societies. Although excess energy intake and physical inactivity are major causes of obesity and cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs) with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic reviews and meta-analyses conducted in recent years strongly support a protective association between eating nuts and CVD. The investigators will conduct a randomized controlled clinical trial in adults. The main research questions are: a. Does consumption of fatty fish increase levels of POPs in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? b. Does consumption of fatty fish affect markers of cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? c. Does consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and 2. to a group consuming fatty fish. Clinical significance of study: If an increase in POP levels is seen, and correlates with cardiometabolic risks, this may indicate the need to look further at a causal relation between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish, this could be important dietary information for populations at high risk of CVD.
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome. A total of 12 patients will initially be enrolled for study participation. A Data Safety Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the 12 patients have completed at least one month of study treatment, the DSMB will meet and determine whether additional patients may be enrolled or the study should be stopped. If the safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36 patients.
Rationale: Subjects with the metabolic syndrome have an increased risk of developing cardiovascular disease and a twofold risk of developing hypertension. A functional food ingredient with the ability to improve arterial stiffness, microcirculation and/or the ability to reduce blood pressure could potentially contribute to the delay or prevention of a range of cardiovascular diseases and could provide additional complimentary alternatives to pharmacological and lifestyle based interventions in the maintenance of cardiovascular health. Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV, characteristics of microcirculation, systolic and diastolic blood pressure, lipid and lipoprotein metabolism, glucose metabolism and incretins. Study design: Investigators propose to carry out a randomized, double-blind, placebo controlled crossover study. Study population: Eligible subjects will be male or female, non-smokers between 18-75 years of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end of the study. Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once daily, on separate occasions, for a period of 4 weeks and with a washout period between the two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or extended by 8 weeks, depending on the availability of the subject. Total study duration will be 10 - 16 weeks, depending on the duration of the washout period. Main study parameters/endpoints: Measurements will be performed at the start and end of each 4-week intervention period. Effects of NWT-03 supplementation will be calculated as the absolute differences between values obtained at each period. The main study endpoint is the change in cr-PWV. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Before the study starts, subjects will be screened to determine eligibility during a screening visit. During this visit, body weight, height, waist circumference and blood pressure will be measured and a venous blood sample (10 mL) will be collected. During the study, subjects will receive NWT-03 and placebo powders in random order and are asked to consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a food frequency questionnaire and to provide a spot urine sample at visits 4 and 7. Furthermore, subjects will be asked to keep a study diary throughout the duration of the study. Total time investment for the subjects will be approximately 19 hours. Apart from bruises or hematoma, rarely induced by blood sampling, no risks are associated with participation in this study.
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.
Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world. Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals: 1) To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.
The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a structured exercise program reduce the progression of carotid and coronary atheromatous lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the number of individuals requiring statins.
AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to usual clinical practice. METHODOLOGY Open label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up: i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to perform scheduled phlebotomies from the third month of treatment to the end of the study (3 times with a 3-month interval between them). ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to follow-up without bloodletting. The whole group of patients will undergo a comprehensive anthropometric and hormonal assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory and office blood pressure monitoring, proinflammatory profile, oxidative stress status, autonomic function assessment, and iron-related metabolism parameters at baseline, after 3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention Group of patients, and throughout follow-up under treatment with COC in the Control Group of patients. If a significant relationship between circulating hepcidin levels and elevated ferritin concentrations is observed, a study of the potential influence of mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.