ObesityNCT03323294
Bioenergetics and Metabolism in Pediatric Populations
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study investigators, research staff, or any qualified personnel will conduct recruitment of study participants using IRB approved advertisement. 175 pre-pubertal children ages 5-9 years old or children diagnosed with type 2 diabetes or insulin resistance ages 5-17 years old will be recruited and may enroll for this study with the goal that 130 subjects stratified across the study groups will complete the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Obesity, Pediatric Health, Type 2 Diabetes, Insulin Resistance, Metformin Therapy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. | |
| Type 2 Diabetes or Insulin Resistant | Obese individuals with Type 2 Diabetes or insulin resistance (n=20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered circulating blood cell bioenergetics
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit altered circulating blood cell bioenergetics.
Measured: After completion of all study visits, approximately 2 years.
Oxidized plasma redox state
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit a more oxidized plasma redox state.
Measured: After completion of all study visits, approximately 2 years.
Alterations in resting energy expenditure
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of decreased resting energy expenditure.
Measured: After completion of all study visits, approximately 2 years.
Alterations in fatty acid oxidation
We hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of impaired fatty acid oxidation (FAO).
Measured: After completion of all study visits, approximately 2 years.
Poor oxidative capacity
The investigators hypothesize that poor oxidative capacity over time may distinguish between metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) phenotypes.
Measured: After completion of all study visits, approximately 2 years.
Predicting Type 2 Diabetes development
The investigators hypothesize that poor oxidative capacity over time may be predictive of Type 2 Diabetes development.
Measured: After completion of all study visits, approximately 2 years.
Bioenergetics in Type 2 Diabetes with metformin
The investigators hypothesize that the change in bioenergetics will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Measured: 6 months
Resting Energy Expenditure in Type 2 Diabetes with metformin
The investigators hypothesize that the change in resting energy expenditure will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Measured: 6 months
Fatty Acid Oxidation in Type 2 Diabetes with metformin
The investigators hypothesize that the change in fatty acid oxidation will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start18 Oct 2017
- Primary completion6 Mar 2020
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Shannon Rose, PhD, Study chair, Arkansas Children's Research InstituteEugenia Carvalho, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323294
- Sponsor's protocol ID
- BMPP
- Other IDs
- 206164, 1P20GM109096-01A1
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2017
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information collected at the study visit, saliva, cheek swabs, blood, urine, and stool samples may be stored indefinitely and may be used for future research studies on pediatric nutrition. Prior to the information collected at the study visit and samples being used for future research studies, the PI will assess the ethics and scientific merit of the proposed research with the samples, and proposed future research will be reviewed by the IRB as may be required. The samples and health information collected for the study visit may be shared with researchers at the University of Arkansas for Medical Sciences, Arkansas Children's Hospital, or Arkansas Children's Research Institute. The samples may be shared with an outside group. The samples will only have a study number and study acronym to maintain confidentiality.
Publications
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.
PubMed 10977060Vincent 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.
PubMed 17924865Civitarese 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.
PubMed 18202132Hesselink 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.
PubMed 27448057Patti 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.
PubMed 20156986Codoner-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.
PubMed 19671090Faienza 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.
PubMed 23052543Marin 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.
PubMed 25881918Matusik 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.
PubMed 25918709Vehapoglu 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.
PubMed 26865084Albuali 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.
PubMed 25254179Codoner-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.
PubMed 19565402Paltoglou 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.
PubMed 25938733Santillan 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.
PubMed 23809001Simoneau 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.
PubMed 7781930
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioenergetics and Metabolism in Pediatric Populations
- ClinicalTrials.gov ID
- NCT03323294
- Acronym / sponsor ID
- BMPP
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Obesity, Pediatric Health, Type 2 Diabetes, Insulin Resistance, Metformin Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Arkansas
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Type 2 Diabetes or Insulin Resistant | – | –Obese individuals with Type 2 Diabetes or insulin resistance (n=20) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study investigators, research staff, or any qualified personnel will conduct recruitment of study participants using IRB approved advertisement. 175 pre-pubertal children ages 5-9 years old or children diagnosed with type 2 diabetes or insulin resistance ages 5-17 years old will be recruited and may enroll for this study with the goal that 130 subjects stratified across the study groups will complete the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Altered circulating blood cell bioenergetics
Time frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit altered circulating blood cell bioenergetics.
Oxidized plasma redox state
Time frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit a more oxidized plasma redox state.
Alterations in resting energy expenditure
Time frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of decreased resting energy expenditure.
Alterations in fatty acid oxidation
Time frame: After completion of all study visits, approximately 2 years.
We hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of impaired fatty acid oxidation (FAO).
Poor oxidative capacity
Time frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may distinguish between metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) phenotypes.
Predicting Type 2 Diabetes development
Time frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may be predictive of Type 2 Diabetes development.
Bioenergetics in Type 2 Diabetes with metformin
Time frame: 6 months
The investigators hypothesize that the change in bioenergetics will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Resting Energy Expenditure in Type 2 Diabetes with metformin
Time frame: 6 months
The investigators hypothesize that the change in resting energy expenditure will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Fatty Acid Oxidation in Type 2 Diabetes with metformin
Time frame: 6 months
The investigators hypothesize that the change in fatty acid oxidation will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 10977060Mokdad 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.
- Background: PubMed 17924865Vincent 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.
- Background: PubMed 18202132Civitarese 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.
- Background: PubMed 27448057Hesselink 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.
- Background: PubMed 20156986Patti 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.
- Background: PubMed 19671090Codoner-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.
- Background: PubMed 23052543Faienza 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.
- Background: PubMed 25881918Marin 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.
- Background: PubMed 25918709Matusik 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.
- Background: PubMed 26865084Vehapoglu 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.
- Background: PubMed 25254179Albuali 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.
- Background: PubMed 19565402Codoner-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.
- Individual participant dataSharing planned: Yes. The information collected at the study visit, saliva, cheek swabs, blood, urine, and stool samples may be stored indefinitely and may be used for future research studies on pediatric nutrition. Prior to the information collected at the study visit and samples being used for future research studies, the PI will assess the ethics and scientific merit of the proposed research with the samples, and proposed future research will be reviewed by the IRB as may be required. The samples and health information collected for the study visit may be shared with researchers at the University of Arkansas for Medical Sciences, Arkansas Children's Hospital, or Arkansas Children's Research Institute. The samples may be shared with an outside group. The samples will only have a study number and study acronym to maintain confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Rose, PhD study chair
Arkansas Children's Research Institute
Eugenia Carvalho, PhD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered circulating blood cell bioenergetics (time frame: After completion of all study visits, approximately 2 years.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323294, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.