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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT03620773 Active, not recruiting - Obesity Clinical Trials

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

IMPROVE-T2D
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=30) before and after vertical sleeve gastrectomy (VSG). To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study prior to vertical sleeve gastrectomy: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

NCT ID: NCT03617185 Active, not recruiting - Obesity Clinical Trials

Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.

NCT ID: NCT03587727 Active, not recruiting - Obesity Clinical Trials

Hepatic Mitochondrial Function in Youth

MANGO
Start date: November 20, 2018
Phase:
Study type: Observational

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

NCT ID: NCT03516201 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Oral Health in Bariatric Patients

Start date: June 15, 2018
Phase:
Study type: Observational

As few is known about the oral health of bariatric patients, this study aimed to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.