Obesity Clinical Trial
Official title:
Mitochondrial Function in Pediatric Obesity
The prevalence of pediatric obesity is increasing at an unprecedented rate. Obese children
are at risk for the development of insulin resistance, relative insulin deficiency and type
2 diabetes mellitus. However, the cause of insulin resistance remains an area of scientific
interest. The study of type 2 diabetes in children is limited by the lack of a non-invasive
method to evaluate insulin resistance. Recent studies have suggested that mitochondrial
dysfunction is associated with, and perhaps predictive of insulin resistance in adult
relatives of individuals with type 2 diabetes. Mitochondria generate energy in muscle tissue
through the production of ATP, and are important in the metabolism of both glucose and fat.
This study evaluates a novel, non invasive, safe method for predicting insulin resistance
and diabetes in children using a magnetic resonance imaging (MRI) based technique to measure
mitochondrial function. We propose to investigate mitochondrial function and glucose
metabolism in obese and non-obese children in early, mid and late puberty. Analyses will be
conducted to investigate the presence of mitochondrial dysfunction in obese children, to
evaluate the contribution of mitochondrial dysfunction to insulin resistance, and to
determine the contribution of pubertal status to mitochondrial dysfunction and insulin
resistance. The successful completion of this study would provide evidence to support the
hypothesis that mitochondrial dysfunction plays a role in insulin resistance and diabetes in
children. In addition, it would provide a new technique for the prediction of disease states
and perhaps lead to the development of preventative therapeutics for insulin resistance and
type 2 diabetes in children.
We hypothesize that mitochondrial dysfunction will mirror the progression of insulin
resistance and precede and predict abnormal glucose metabolism in a population with
pediatric obesity
Aim I: A cross sectional study to evaluate baseline mitochondrial function in obese children
compared to non-obese children. Determine whether children with pediatric obesity have
impaired mitochondrial function based on 31P magnetic resonance spectroscopy when compared
to healthy non-obese control children.Examine the relationship between mitochondrial
function and insulin resistance in obese and non-obese children. Determine the impact of
pubertal stage on mitochondrial function in obese and non-obese children.
Aim II:A prospective evaluation to determine in a longitudinal cohort study the timing and
relationship of mitochondrial dysfunction to the development of insulin resistance in
prepubertal/early pubertal obese children compared to prepubertal/early pubertal non-obese
children. Determine in a longitudinal cohort study if obese children with mitochondrial
dysfunction develop greater insulin resistance and/or impaired glucose tolerance at an
earlier time point. Evaluate the relationship of obesity, timing of puberty and related
changes in hormone levels to mitochondrial function and the development of insulin
resistance and/or impaired glucose tolerance in longitudinal analyses.
;
Observational Model: Case Control
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |