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Metabolic Diseases clinical trials

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NCT ID: NCT01662193 Recruiting - Clinical trials for Nutritional and Metabolic Disease

Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients

Start date: February 2012
Phase: N/A
Study type: Interventional

The epidemic of type 2 diabetes is an enormous public health problem in all parts of the world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory biomarkers are known as a new risk factor for diabetes. There is accumulating evidence suggesting that altered vitamin D and calcium homeostasis affect the development of type 2 diabetes, but it is still unclear whether that effects are through reducing the level of adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate the effects of vitamin D and calcium supplementations alone and in combination on inflammatory biomarkers and adypocytokines in type 2 diabetic patients. This study is a single masked, controlled randomized trial with period of 8 weeks. 120 diabetic patients who met the inclusion criteria will enroll in this study. Subjects will randomly assign in to four groups. Randomization will be achieved by permuted blocks with stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive 50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus 100 of mg calcium carbonate per day and group four will receive calcium and vitamin D placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin, HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the baseline and at the end of intervention. Systolic and diastolic blood pressure and anthropometric measurements (height, weight, hip and waist circumferences) will be measured at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity records will be taken at 2,4 and 6 week of intervention to make sure that all subjects maintain their usual diet and physical activity during intervention.

NCT ID: NCT01655017 Completed - Obesity Clinical Trials

Fibrosis a New Pathological Actor in Adipose Tissue

fibrota
Start date: February 8, 2012
Phase: N/A
Study type: Interventional

Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness. Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.

NCT ID: NCT01628705 Completed - Clinical trials for Nutritional and Metabolic Disease

Moderated-fat Diet Complemented With Green Tea Reduces oxLDL and Fat Mass in Obese Women

GTRoxLDL
Start date: April 2007
Phase: Phase 4
Study type: Interventional

Background: Obesity is a chronic degenerative disease, considered as cardiovascular risk factor, characterized by systemic inflammation and high levels of oxLDL. Clinical studies have suggested that drink green tea could improve these complications. Objective: Analyze the effect of a moderate-fat diet complemented with green tea on oxLDL, fat mass and TNFa in obese women. Design: Randomized, controlled clinical trial. Obese women, without other chronic-degenerative disease were divided using a computer-generated random sequence: control group (CON) with n=32, and intervention group (INT) with n=32; and were instructed to consume a moderate-fat diet, and INT group was instructed to complement the diet with green tea. Anthropometric and biochemical measurements were performed, and oxLDL and TNFa s levels were determined by ELISA. All parameters were realized at baseline and in the 1st, 2nd and 3rd months post-intervention. TNFa mRNA expression was determined by real-time RT-PCR (basal and final). The changes on lipid profile, oxLDL, fat mass and TNFalpha expression were reported of the comparison between basal and final time points. The statistical analysis was performed with SPSS software.

NCT ID: NCT01616082 Completed - Obesity Clinical Trials

Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)

MagellanII
Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to better understand the different ways our bodies burn fat which may be important for obesity, diabetes, and cardiovascular disease.

NCT ID: NCT01596699 Terminated - Metabolic Disease Clinical Trials

Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation

Start date: May 24, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has. The study will also look at what causes some people to have high drug levels of these medications in their body compared to other people that may have low drug levels even if they all receive the same dose of medication.

NCT ID: NCT01593501 Completed - Clinical trials for Magnesium Deficiency

How Does Magnesium Status Influence Calcium Homeostasis?

Start date: May 2012
Phase: Phase 4
Study type: Interventional

The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). In this trial, the investigators propose to evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D). The investigators already assess calcium homeostasis throughout the study by measuring bone mineral density, fractional calcium absorption, serum and urine calcium levels, among other tests. In the sub-study of 60 women, the investigators will evaluate whether habitually higher magnesium intake increases or decreases fractional calcium absorption. The investigators will evaluate the interplay between magnesium stores, vitamin D levels and serum parathyroid hormone levels. The investigators will directly assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium absorption using the dual stable isotope approach.

NCT ID: NCT01571843 Completed - Clinical trials for Osteoporosis, Postmenopausal

Radius Loading in Primary Hyperparathyroidism

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effect of forearm exercise on forearm bone density in post-menopausal women with or without primary hyperparathyroidism. The investigators hypothesize that forearm exercise will increase forearm bone density in patients with primary hyperparathyroidism more so than in patients without primary hyperparathyroidism.

NCT ID: NCT01571609 Completed - Obesity Clinical Trials

Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.

NCT ID: NCT01569724 Completed - Clinical trials for Hypertriglyceridemia

Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma

TgBEX
Start date: January 2012
Phase: Phase 4
Study type: Interventional

Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

NCT ID: NCT01554254 Withdrawn - Clinical trials for Hematologic Malignancy

Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells from UCB. TXA127 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (which contains the 8th amino acid conferring receptor binding to blood pressure receptors). TXA127 has multilineage effects on hematopoietic progenitors in vitro and in vivo. Preclinical data show that TXA127 is a novel stimulator of early multilineage hematopoietic progenitors, increases engraftment of committed hematopoietic progenitors, and induces more rapid production of platelets and neutrophils in the peripheral circulation, especially in limited cell number transplants. Treatment with TXA127 following UCBT is expected to increase the numbers of hematopoietic progenitors and accelerate engraftment.