Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
79 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-10-18
Study Completion Date
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators want to learn more about obesity, the development of insulin resistance, and Type 2 Diabetes in children. The investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
NCT05055219
PreDiabetes
Obesity, Childhood
COMPLETED
Reversal of Lipid-Induced Insulin Resistance
NCT02193295
Insulin Resistance
NAFLD
RECRUITING
NA
The Effects of Puberty and Weight on Sugar Metabolism in Children
NCT01718080
Overweight
Leanness
Adolescent
COMPLETED
Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth
NCT00536250
Impaired Glucose Tolerance
Pre-diabetes
Childhood Obesity
+2 more
COMPLETED
Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity
NCT00523562
Metabolic Syndrome X
Liver Diseases
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Obesity
Type 2 Diabetes Mellitus
Insulin Resistance
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy Lean
Healthy lean individuals (n=20) defined with a Body Mass Index (BMI) ≥ 5th percentile and \<85th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit.
No interventions assigned to this group
Healthy Obese
Healthy obese individuals (n=20) defined with a Body Mass Index (BMI) ≥ 95th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit.
No interventions assigned to this group
Obese Insulin Resistant
Obese insulin resistant individuals (n=70) as defined with a Body Mass Index (BMI) ≥ 95th percentile for age/sex and will be recruited. Participants will be asked to complete a total of 2 study visits. The second study visit will occur at 12 months (± 2 weeks) after the initial study visit.
No interventions assigned to this group
Type 2 Diabetes or Insulin Resistant
Obese individuals with Type 2 Diabetes or insulin resistance (n=20)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 5-9 years and Tanner stage as reported by parent no greater than stage 1 OR Age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance
* Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex)
* For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment
* Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex)
* For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment
Exclusion Criteria
* Genetic or physical conditions impacting mobility over past year as determined by the Principal Investigator (PI)
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
* Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
* BMI\<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)
* Subjects determined ineligible by the PI.
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
* Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
* BMI\<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)
* Subjects determined ineligible by the PI.
Minimum Eligible Age
5 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute of General Medical Sciences (NIGMS)
NIH
Sponsor Role
collaborator
University of Arkansas
OTHER
Sponsor Role
collaborator
Arkansas Children's Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shannon Rose, PhD
Role: STUDY_CHAIR
Arkansas Children's Research Institute
Eugenia Carvalho, PhD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Nutrition Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000 Sep;23(9):1278-83. doi: 10.2337/diacare.23.9.1278.
Reference Type
BACKGROUND
Vincent HK, Innes KE, Vincent KR. Oxidative stress and potential interventions to reduce oxidative stress in overweight and obesity. Diabetes Obes Metab. 2007 Nov;9(6):813-39. doi: 10.1111/j.1463-1326.2007.00692.x.
Reference Type
BACKGROUND
Civitarese AE, Ravussin E. Mitochondrial energetics and insulin resistance. Endocrinology. 2008 Mar;149(3):950-4. doi: 10.1210/en.2007-1444. Epub 2008 Jan 17.
Reference Type
BACKGROUND
Hesselink MK, Schrauwen-Hinderling V, Schrauwen P. Skeletal muscle mitochondria as a target to prevent or treat type 2 diabetes mellitus. Nat Rev Endocrinol. 2016 Nov;12(11):633-645. doi: 10.1038/nrendo.2016.104. Epub 2016 Jul 22.
Reference Type
BACKGROUND
Patti ME, Corvera S. The role of mitochondria in the pathogenesis of type 2 diabetes. Endocr Rev. 2010 Jun;31(3):364-95. doi: 10.1210/er.2009-0027. Epub 2010 Feb 15.
Reference Type
BACKGROUND
Codoner-Franch P, Pons-Morales S, Boix-Garcia L, Valls-Belles V. Oxidant/antioxidant status in obese children compared to pediatric patients with type 1 diabetes mellitus. Pediatr Diabetes. 2010 Jun;11(4):251-7. doi: 10.1111/j.1399-5448.2009.00565.x. Epub 2009 Sep 16.
Reference Type
BACKGROUND
Faienza MF, Francavilla R, Goffredo R, Ventura A, Marzano F, Panzarino G, Marinelli G, Cavallo L, Di Bitonto G. Oxidative stress in obesity and metabolic syndrome in children and adolescents. Horm Res Paediatr. 2012;78(3):158-64. doi: 10.1159/000342642. Epub 2012 Oct 10.
Reference Type
BACKGROUND
Marin MT, Dasari PS, Tryggestad JB, Aston CE, Teague AM, Short KR. Oxidized HDL and LDL in adolescents with type 2 diabetes compared to normal weight and obese peers. J Diabetes Complications. 2015 Jul;29(5):679-85. doi: 10.1016/j.jdiacomp.2015.03.015. Epub 2015 Apr 6.
Reference Type
BACKGROUND
Matusik P, Prokopowicz Z, Norek B, Olszanecka-Glinianowicz M, Chudek J, Malecka-Tendera E. Oxidative/Antioxidative status in obese and sport trained children: a comparative study. Biomed Res Int. 2015;2015:315747. doi: 10.1155/2015/315747. Epub 2015 Mar 31.
Reference Type
BACKGROUND
Vehapoglu A, Turkmen S, Goknar N, Ozer OF. Reduced antioxidant capacity and increased subclinical inflammation markers in prepubescent obese children and their relationship with nutritional markers and metabolic parameters. Redox Rep. 2016 Nov;21(6):271-80. doi: 10.1080/13510002.2015.1133035. Epub 2016 Feb 19.
Reference Type
BACKGROUND
Albuali WH. Evaluation of oxidant-antioxidant status in overweight and morbidly obese Saudi children. World J Clin Pediatr. 2014 Feb 8;3(1):6-13. doi: 10.5409/wjcp.v3.i1.6. eCollection 2014 Feb 8.
Reference Type
BACKGROUND
Codoner-Franch P, Boix-Garcia L, Simo-Jorda R, Del Castillo-Villaescusa C, Maset-Maldonado J, Valls-Belles V. Is obesity associated with oxidative stress in children? Int J Pediatr Obes. 2010;5(1):56-63. doi: 10.3109/17477160903055945.
Reference Type
BACKGROUND
Paltoglou G, Fatouros IG, Valsamakis G, Schoina M, Avloniti A, Chatzinikolaou A, Kambas A, Draganidis D, Mantzou A, Papagianni M, Kanaka-Gantenbein C, Chrousos GP, Mastorakos G. Antioxidation improves in puberty in normal weight and obese boys, in positive association with exercise-stimulated growth hormone secretion. Pediatr Res. 2015 Aug;78(2):158-64. doi: 10.1038/pr.2015.85. Epub 2015 May 4.
Reference Type
BACKGROUND
Santillan LD, Moyano M, Frau M, Flores O, Siewert S, Zirulnick F, Ramirez DC, Gimenez MS. Reduced blood nrf-2 mRNA in local overweight boys at risk of metabolic complications: a study in San Luis City, San Luis, Argentina. Metab Syndr Relat Disord. 2013 Oct;11(5):359-65. doi: 10.1089/met.2012.0155. Epub 2013 Jun 28.
Reference Type
BACKGROUND
Simoneau JA, Colberg SR, Thaete FL, Kelley DE. Skeletal muscle glycolytic and oxidative enzyme capacities are determinants of insulin sensitivity and muscle composition in obese women. FASEB J. 1995 Feb;9(2):273-8.
Reference Type
BACKGROUND
Simoneau JA, Bouchard C. Skeletal muscle metabolism and body fat content in men and women. Obes Res. 1995 Jan;3(1):23-9. doi: 10.1002/j.1550-8528.1995.tb00117.x.
Reference Type
BACKGROUND
Simoneau JA, Kelley DE. Altered glycolytic and oxidative capacities of skeletal muscle contribute to insulin resistance in NIDDM. J Appl Physiol (1985). 1997 Jul;83(1):166-71. doi: 10.1152/jappl.1997.83.1.166.
Reference Type
BACKGROUND
Simoneau JA, Kelley DE, Neverova M, Warden CH. Overexpression of muscle uncoupling protein 2 content in human obesity associates with reduced skeletal muscle lipid utilization. FASEB J. 1998 Dec;12(15):1739-45. doi: 10.1096/fasebj.12.15.1739.
Reference Type
BACKGROUND
Kelley DE, Goodpaster B, Wing RR, Simoneau JA. Skeletal muscle fatty acid metabolism in association with insulin resistance, obesity, and weight loss. Am J Physiol. 1999 Dec;277(6):E1130-41. doi: 10.1152/ajpendo.1999.277.6.E1130.
Reference Type
BACKGROUND
Ritov VB, Menshikova EV, He J, Ferrell RE, Goodpaster BH, Kelley DE. Deficiency of subsarcolemmal mitochondria in obesity and type 2 diabetes. Diabetes. 2005 Jan;54(1):8-14. doi: 10.2337/diabetes.54.1.8.
Reference Type
BACKGROUND
Ritov VB, Menshikova EV, Azuma K, Wood R, Toledo FG, Goodpaster BH, Ruderman NB, Kelley DE. Deficiency of electron transport chain in human skeletal muscle mitochondria in type 2 diabetes mellitus and obesity. Am J Physiol Endocrinol Metab. 2010 Jan;298(1):E49-58. doi: 10.1152/ajpendo.00317.2009. Epub 2009 Nov 3.
Reference Type
BACKGROUND
Kelley DE, He J, Menshikova EV, Ritov VB. Dysfunction of mitochondria in human skeletal muscle in type 2 diabetes. Diabetes. 2002 Oct;51(10):2944-50. doi: 10.2337/diabetes.51.10.2944.
Reference Type
BACKGROUND
Patti ME, Butte AJ, Crunkhorn S, Cusi K, Berria R, Kashyap S, Miyazaki Y, Kohane I, Costello M, Saccone R, Landaker EJ, Goldfine AB, Mun E, DeFronzo R, Finlayson J, Kahn CR, Mandarino LJ. Coordinated reduction of genes of oxidative metabolism in humans with insulin resistance and diabetes: Potential role of PGC1 and NRF1. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8466-71. doi: 10.1073/pnas.1032913100. Epub 2003 Jun 27.
Reference Type
BACKGROUND
Sreekumar R, Halvatsiotis P, Schimke JC, Nair KS. Gene expression profile in skeletal muscle of type 2 diabetes and the effect of insulin treatment. Diabetes. 2002 Jun;51(6):1913-20. doi: 10.2337/diabetes.51.6.1913.
Reference Type
BACKGROUND
Ten S, Bhangoo A, Ramchandani N, Mueller C, Vogiatzi M, New M, Lesser M, Maclaren N. Resting energy expenditure in insulin resistance falls with decompensation of insulin secretion in obese children. J Pediatr Endocrinol Metab. 2008 Apr;21(4):359-67. doi: 10.1515/JPEM.2008.21.4.359.
Reference Type
BACKGROUND
De Pergola G, Pannacciulli N, Minenna A, Martina RA, Cannito F, Giorgino R. Fuel metabolism in adult individuals with a wide range of body mass index: effect of a family history of type 2 diabetes. Diabetes Nutr Metab. 2003 Feb;16(1):41-7.
Reference Type
BACKGROUND
Chacko BK, Kramer PA, Ravi S, Benavides GA, Mitchell T, Dranka BP, Ferrick D, Singal AK, Ballinger SW, Bailey SM, Hardy RW, Zhang J, Zhi D, Darley-Usmar VM. The Bioenergetic Health Index: a new concept in mitochondrial translational research. Clin Sci (Lond). 2014 Sep;127(6):367-73. doi: 10.1042/CS20140101.
Reference Type
BACKGROUND
Kramer PA, Chacko BK, Ravi S, Johnson MS, Mitchell T, Darley-Usmar VM. Bioenergetics and the oxidative burst: protocols for the isolation and evaluation of human leukocytes and platelets. J Vis Exp. 2014 Mar 27;(85):51301. doi: 10.3791/51301.
Reference Type
BACKGROUND
Tyrrell DJ, Bharadwaj MS, Van Horn CG, Marsh AP, Nicklas BJ, Molina AJ. Blood-cell bioenergetics are associated with physical function and inflammation in overweight/obese older adults. Exp Gerontol. 2015 Oct;70:84-91. doi: 10.1016/j.exger.2015.07.015. Epub 2015 Jul 29.
Reference Type
BACKGROUND
Nijhawan S, Richards W, O'Hea MF, Audia JP, Alvarez DF. Bariatric surgery rapidly improves mitochondrial respiration in morbidly obese patients. Surg Endosc. 2013 Dec;27(12):4569-73. doi: 10.1007/s00464-013-3125-y. Epub 2013 Aug 24.
Reference Type
BACKGROUND
Tyrrell DJ, Bharadwaj MS, Jorgensen MJ, Register TC, Molina AJ. Blood cell respirometry is associated with skeletal and cardiac muscle bioenergetics: Implications for a minimally invasive biomarker of mitochondrial health. Redox Biol. 2016 Dec;10:65-77. doi: 10.1016/j.redox.2016.09.009. Epub 2016 Sep 21.
Reference Type
BACKGROUND
Bervoets L, Massa G. Classification and clinical characterization of metabolically "healthy" obese children and adolescents. J Pediatr Endocrinol Metab. 2016 May 1;29(5):553-60. doi: 10.1515/jpem-2015-0395.
Reference Type
BACKGROUND
Munoz-Garach A, Cornejo-Pareja I, Tinahones FJ. Does Metabolically Healthy Obesity Exist? Nutrients. 2016 Jun 1;8(6):320. doi: 10.3390/nu8060320.
Reference Type
BACKGROUND
Rose S, Frye RE, Slattery J, Wynne R, Tippett M, Melnyk S, James SJ. Oxidative stress induces mitochondrial dysfunction in a subset of autistic lymphoblastoid cell lines. Transl Psychiatry. 2014 Apr 1;4(4):e377. doi: 10.1038/tp.2014.15.
Reference Type
BACKGROUND
Rose S, Frye RE, Slattery J, Wynne R, Tippett M, Pavliv O, Melnyk S, James SJ. Oxidative stress induces mitochondrial dysfunction in a subset of autism lymphoblastoid cell lines in a well-matched case control cohort. PLoS One. 2014 Jan 8;9(1):e85436. doi: 10.1371/journal.pone.0085436. eCollection 2014.
Reference Type
BACKGROUND
Santos D, Porter-Gill P, Goode G, Delhey L, Sorensen AE, Rose S, Borsheim E, Dalgaard LT, Carvalho E. Circulating microRNA levels differ in the early stages of insulin resistance in prepubertal children with obesity. Life Sci. 2023 Jan 1;312:121246. doi: 10.1016/j.lfs.2022.121246. Epub 2022 Nov 28.
Reference Type
RESULT
Barbosa P, Landes RD, Graw S, Byrum SD, Bennuri S, Delhey L, Randolph C, MacLeod S, Reis A, Borsheim E, Rose S, Carvalho E. Effect of excess weight and insulin resistance on DNA methylation in prepubertal children. Sci Rep. 2022 May 19;12(1):8430. doi: 10.1038/s41598-022-12325-y.
Reference Type
RESULT
Barbosa P, Melnyk S, Bennuri SC, Delhey L, Reis A, Moura GR, Borsheim E, Rose S, Carvalho E. Redox Imbalance and Methylation Disturbances in Early Childhood Obesity. Oxid Med Cell Longev. 2021 Aug 17;2021:2207125. doi: 10.1155/2021/2207125. eCollection 2021.
Reference Type
RESULT
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
206164
Identifier Type: OTHER
Identifier Source: secondary_id
BMPP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Novel Therapies for Metabolic Complications of Lipodystrophies
NCT00457938
COMPLETED
NA
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
NCT03379792
COMPLETED
Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
NCT01755962
COMPLETED
NA
Prevalence of Carbohydrate Intolerance in Lean and Obese Children
NCT00000112
UNKNOWN
Low Carbohydrate Diet: The Effects on Non Alcoholic Fatty Liver Disease in Obese Teens With Metabolic Syndrome
NCT02358928
COMPLETED
NA
Identification of New Biomarkers of Insulin Resistance
NCT03362554
ACTIVE_NOT_RECRUITING
NA
De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease
NCT00714129
COMPLETED
NA
Effects of Excess Energy Intake on Metabolic Risk
NCT00562393
COMPLETED
NA
Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
NCT00830999
COMPLETED
NA
Individual Metabolism and Physiology Signature Study
NCT02298725
COMPLETED
NA
Investigating Brown Adipose Tissue Activation in Humans
NCT01935791
COMPLETED
NA
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
NCT05268042
RECRUITING
NA
Insulin Resistance in Severely Obese Patients
NCT00275223
COMPLETED
Fat Induced Insulin Resistance and Atherosclerosis
NCT02348190
COMPLETED
NA
The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
NCT05545306
RECRUITING
NA
Effect of Obesity-derived Cytokines on Protein Turnover and Carbohydrate Metabolism in Human Skeletal Muscle
NCT02305069
COMPLETED
NA
Factors Involved in Obesity-related Inflammation and Insulin Resistance
NCT01173705
TERMINATED
Effect of Increased Free Fatty Acids on Leptin Function
NCT01520454
COMPLETED
NA
Study of Fat Tissue's Ability to Take up Sugar in the Obese Population
NCT02994459
ACTIVE_NOT_RECRUITING
Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
NCT02011581
COMPLETED
Breakfast and Energy Expenditure in Young Women
NCT03079635
COMPLETED
NA
Health Effects of Liposuction in Overweight Women With Elevated Insulin Levels, Impaired Glucose Tolerance and/or Type 2 Diabetes
NCT00005760
COMPLETED
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
NCT02783703
COMPLETED
NA
Effect of Endoplasmic Reticulum Stress on Metabolic Function
NCT00771901
COMPLETED
NA
Novel Biomarker for Development of T2D
NCT02326129
COMPLETED