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Adolescent Obesity clinical trials

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NCT ID: NCT03762629 Recruiting - Childhood Obesity Clinical Trials

Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents

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

Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may already be associated with serious comorbidities, obese adolescents are at significantly higher risk for obesity and increased morbidity and mortality during adulthood. Combined lifestyle interventions, which include regular physical activity and dietary restriction, have been shown to result in most significant improvements in cardiovascular function and their associated factors in the pediatric and adolescent population with obesity. The aim of this study is to investigate the effects of a combined exercise and diet intervention on cardiovascular function and their associated factors in obese children.

NCT ID: NCT03620773 Recruiting - Obesity Clinical Trials

Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes

Start date: October 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD. Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease. The investigators' overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on intrarenal hemodynamics is mediated by improvement in IR and weight loss. To address these hypotheses, the investigators will measure GFR, RPF, glomerular pressure and renal O2, in addition to aortic stiffness, β-cell function and insulin sensitivity in youth ages 12-21 with T2D (n=15) before and after vertical sleeve gastrectomy (VSG).

NCT ID: NCT03587727 Not yet recruiting - Obesity Clinical Trials

Hepatic Mitochondrial Function in Youth

Start date: December 1, 2018
Study type: Observational

Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth

NCT ID: NCT03584217 Recruiting - Obesity Clinical Trials

Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study

Start date: October 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Hyperfiltration is common in youth with T2D, and predicts progressive DKD. Hyperfiltration may also be associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Despite the high prevalence and gravity of DKD in youth-onset T2D, widely effective therapeutic options are lacking. The investigators' preliminary data support a strong association between IR and hyperfiltration in youth-onset T2D, but the pathology contributing to this relationship remains unclear. A better understanding of the pathophysiology underlying hyperfiltration and its relationship with IR is critical to inform development of new therapeutics. The investigators' overarching hypotheses are that: 1) hyperfiltration in youth-onset T2D is associated with changes in intrarenal hemodynamics, resulting in increased renal oxygen demand, 2) the demand is unmet by the inefficient fuel profile associated with IR (decreased glucose oxidation and increase free fatty acid [FFA] oxidation), resulting in renal hypoxia and ultimately renal damage. To address these hypotheses, the investigators will measure peripheral insulin sensitivity, adipose insulin sensitivity (FFA suppression), glomerular filtration rate (GFR), RPF, and renal oxygenation in youth with T2D (n=30), obesity (n=20) and in lean (n=20) controls.

NCT ID: NCT03567837 Recruiting - Adolescent Obesity Clinical Trials

Fructose-induced Hepatic De Novo Lipogenesis in Adolescents With Obesity

Start date: August 13, 2018
Phase: N/A
Study type: Interventional

In the U.S., dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group. This protocol will compare the rates of hepatic de novo lipogenesis (DNL), a process in the liver that changes sugar into fat, in two groups of obese adolescents - one with prediabetes and the other, metabolically healthy. Blood will be sampled before and hourly for 3 hours after the consumption of a fructose-containing beverage. We hypothesize that the pre-diabetic group will show greater DNL in response to fructose. This would support other evidence that increased fructose-induced hepatic DNL is an early mechanism linking dietary sugar to the adverse metabolic sequelae of obesity, including diabetes, fatty liver, dyslipidemia and coronary disease.

NCT ID: NCT03561597 Recruiting - Adolescent Obesity Clinical Trials

Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Background: The Expert Committee on the Assessment, Prevention and Treatment of Child and Adolescent Overweight and Obesity recommends a staged based approach to the management of adolescents with overweight and obesity from Stage 1-4 with increasing intensity of management in higher stages. Mobile health application is an attractive community based treatment for adolescent obesity due to its wide penetration and convenience. Early weight loss has been found to be the strongest predictor of good long term outcome in obesity. However there is currently no known study that use early weight loss as a predictor factor for a stepped up approach using a mobile health application. Clinical significance: The current study use a mobile health intervention to identify participants with early weight loss in a stepped up approach. Primary objective will be to examine the proportion of patients triaged to the low risk Weight Management Clinics (WMC) after brief intervention by a nurse coordination and completion of 4 sessions of Kurbo Program over a 12 month recruitment period. Secondary objectives will be to examine changes in BMI z-score, metabolic profile, examine program feasibility and fidelity and explore other predictors of poor response to program. Methodology: Children aged 13-17 years old with BMI percentile of above 90th percentile, who are referred to the WMC, will receive a brief intervention by the WMC nurse coordinator followed by introduction to Kurbo program, a multifunctional mobile application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic. At baseline, month 3 and month 6, the patient's weight and height, body fat composition, waist circumference and blood pressure will be measured as per usual standard protocol. Questionnaires to assess eating, quality of life and dietary recall will be administered as part of the research. Accelerometers will also be fitted to assess physical activity. At baseline and month 6, metabolic blood tests (HbA1C, fasting lipid panel, oral glucose tolerance test, fasting insulin level and liver function test) were collected after a minimum 8 hour fasting period together with bloods for aromatic amino acid, branch chain amino acid and long chain acylcarnitines . Current low risk WMC patients will be offered 2 monthly follow up with optional dietician and exercise physiologists counselling and exercise sessions. The high risk WMC patients will be routinely offered the standard high risk follow up protocol consisting of weekly follow up with the multidisciplinary team for 4 weeks followed by 2 weekly appointments for 2 months and monthly appointment thereafter based on clinical response.

NCT ID: NCT03516721 Completed - Obesity Clinical Trials

Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly prevalent in obese populations. This phenomenon is also known as chronotropic incompetence (CI). In adult obese individuals, CI is independently related to elevated risk for major adverse cardiovascular events and premature death. Despite the established association between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents with obesity has however deserved no attention, but is important. CI during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. However, whether CI during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. In addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. In this project, we examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between CI and changes in CPET parameters, lactate, catecholamine and potassium concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG recording). In addition, the relation between CI and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.

NCT ID: NCT03516097 Not yet recruiting - Adolescent Obesity Clinical Trials

TeenPower: e-Empowering Teenagers to Prevent Obesity

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

Transdisciplinary practice-based action research project that aims to develop innovative cognitive-behavioral interventions to empower adolescents, through increased and interactive contact between adolescent and multidisciplinary healthcare team. Project born from the discussion with trans-territorial stakeholders (health professionals and school communities), in the absence of an integrated, creative and dynamic strategy of overweight prevention and promotion of salutogenic behaviors in adolescents. The polytechnics of Leiria, Santarém and Castelo Branco are co-promotors of this project, as well as Município de Leiria (City Council), key partners in the development and implementation of the intervention program. It is expected the partnership with ARS-Centro. The main goal is the development, implementation and evaluation of a program for the promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy and sustained by the case management methodology.

NCT ID: NCT03469752 Recruiting - Physical Activity Clinical Trials

Latino Fathers Promoting Healthy Youth Behaviors

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.

NCT ID: NCT03458637 Completed - Adolescent Obesity Clinical Trials

Lifestyle Intervention of Obese Teenagers (LITE) Program

Start date: November 6, 2014
Phase: N/A
Study type: Interventional

Background: Family-based lifestyle intervention programmes have been known to reduce overweight and improve cardiovascular risk in adolescent obesity [1]. This study was designed to address the gap in service provision of a family based weight management program for overweight and obese adolescents. The LITE (Lifestyle Intervention for obese teenagers) group program is a 6-month, family-based behavioural lifestyle intervention, specifically designed to treat obesity in adolescents 10-16 years referred to the Weight Management Clinic. The main principles underpinning LITE program are that parents are identified as the agents of change responsible for implementing lifestyle change in the family . Methods: The study design is a two-arm randomized controlled trial that recruited 60 overweight and obese adolescents 10-16 year olds that attended Kandang Kerbau Women and Children's Hospital(KKH) weight management clinic. Adolescents with secondary cause for obesity are excluded. Participants are randomized to LITE program with usual care or usual care. Briefly, the LITE program involves four x 180 min weekly sessions, followed by three x 90 min monthly sessions, for adolescents and parents. The key aspects covered in the LITE program are in keeping with Health Promotion Board guidelines for the management of overweight and obesity and include healthy food choices and eating patterns, increasing physical activity and reducing sedentary behavior. The parenting aspects aim to support and increase parental capacity to implement and maintain the lifestyle changes. The program takes a solution focused approach with families identifying small changes that they would like to try each week instead of a child-centric approach. Outcome measurement are assessed at 3 and 6 months post baseline and include anthropometric measurements, physical activity, dietary intake, metabolic profile, improvement in positive parenting behaviour and measurement of family support. Primary outcome is change in body mass index (BMI) z-score at 6 months. Secondary aim is to evaluate the changes in waist-height ratio and fat percentage change and improvement in positive parenting behaviour.