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Obese clinical trials

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NCT ID: NCT03083964 Completed - Obese Clinical Trials

Addressing Place and People Micro Environments in Weight Loss Disparities

APP-ME
Start date: January 18, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to A) capture obesogenic cues that occur in daily life, and B) to deliver cue alerts. Investigators hypothesized that A) black women experience more cues, B) racial disparities in obesity are reduced in models that adjust for cues, and C) the priming arm will achieve a weight loss of 2kg or more. Investigators will explore whether racial disparities in weight loss differ between the groups receiving usual care or those receiving cues.

NCT ID: NCT03052062 Completed - Obese Clinical Trials

Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03)

Start date: March 2, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this clinical study are to determine the tolerance of dietary supplement Lipidrive through the evaluation of several parameters : - Various blood biological parameters - Urinary parameters - Hemodynamic indicators - Cardiac function - Anthropometric variables

NCT ID: NCT03029715 Completed - Obese Clinical Trials

Anaesthesia for Laparoscopic Sleeve Gastrectomy

Start date: February 2014
Phase: N/A
Study type: Interventional

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study was carried out to compare the use of inhalation anaesthesia technique using desflurane and TIVA using propofol and dexmedetomidine. Methods: This randomized controlled trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion. Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and post-anaesthetic care unit (PACU) stay were studied for both groups.

NCT ID: NCT03024723 Completed - Obese Clinical Trials

Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient

Start date: April 2015
Phase: N/A
Study type: Observational

The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success in patients with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia. The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients under anesthesia. The investigators propose to test this hypothesis and determine the efficacy of nCPAP on maintaining airway patency in obese patients who require general anesthesia compared with CPAP administering face mask.

NCT ID: NCT03024359 Completed - Obese Clinical Trials

Monounsaturated Fatty Acids and Brown/Beige Adipose Tissue in Humans

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

Considering the high prevalence of obesity its comorbidities in Brazil and in the world, different therapeutic measures have been suggested. It is currently known that brown/beige adipose tissue plays an important role in body weight control and there is strong evidence that its activity is inversely associated with obesity and metabolic diseases. Recent studies have shown an important role foods and nutrients in the activation of brown/beige adipose tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to metabolism have been described in several studies, however, the effects of consuming large amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been explored. The aim of the study is to evaluate the impact of the consumption of large amounts of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls (normal weight) participants will undergo a dietary intervention for 4 weeks with extra virgin olive oil. Before and after the intervention period several data will be collected: dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with 18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging - PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and standard deviation and the variables compared by the Student t test or ANOVA for repeated measures.

NCT ID: NCT03000907 Completed - Sarcopenia Clinical Trials

Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB)

PRE-FROB
Start date: January 23, 2017
Phase: N/A
Study type: Interventional

Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese people usually perform less physical activity. All this favors the loss of mass and muscular function (sarcopenia), a key component of the fragility and the functional deterioration. Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the prevention of frailty in obese elderly people, as well as to know the main mechanisms involved in the frailty process. Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of age, obese (BMI ≥30), without criteria of fragility and living in the community. Study intervention: multimodal and personalized intervention with the support of a "personal trainer" that has two main axes of action: a) diet: assessment of nutritional status and nutritional requirements and establishment of personalized nutritional plan with monthly dietetic controls and b) physical exercise: a multi-component physical exercise program that will include aerobic exercise and strengthening, balance and flexibility exercises as well as a weekly group session of health education, during six months. Main outcome measures (to be evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia (according to the criteria of the European Working Group on Sarcopenia in Older People -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in body composition and distribution of body fat, c) glycemic control (HbA1) and insulin resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).

NCT ID: NCT02993861 Completed - Epilepsy Clinical Trials

Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Start date: December 9, 2016
Phase:
Study type: Observational

The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).

NCT ID: NCT02960386 Completed - Overweight Clinical Trials

An Engagement Engine for Fitness Trackers

iTrackFitnes
Start date: January 2016
Phase: N/A
Study type: Interventional

The iTrackFitness study aims to test the "engagement engine" that was developed from activity tracker and survey data gathered during phase I of the study. For the current phase the "engagement engine" will support successful and sustained engagement with health trackers thereby increasing physical activity.

NCT ID: NCT02919176 Completed - Metabolic Syndrome Clinical Trials

Brown Fat Activation Study

Start date: September 1, 2016
Phase: Early Phase 1
Study type: Interventional

This is an open lable, pilot study in which the investigator will research the effect of two FDA approved drugs, Mirabegron and Pioglitazone on fat tissue. Pioglitazone is drug approved by the FDA for the treatment of diabetes and Mirabegron is a drug that is approved by the FDA for the treatment of overactive bladder. These drugs are not approved by the FDA for the purposes being studied in this research. Therefore, the way in which the investigator intends to use them in this study are considered investigational.

NCT ID: NCT02871882 Completed - Clinical trials for Type 2 Diabetes Mellitus

Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

Start date: September 15, 2016
Phase: Phase 2
Study type: Interventional

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.