ObesityNCT00000112
Prevalence of Carbohydrate Intolerance in Lean and Obese Children
An observational study of Obesity and Glucose Intolerance, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. Insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Glucose Intolerance, Diabetes
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obesity: BM +/- 95% for age general good health
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine, Pediatric Endocrinology
New Haven, Connecticut, 06520-8064
About this study
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. Insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and obese children with acanthosis nigricans with or without a family history of diabetes mellitus will be studied.
- Conditions
- Obesity, Glucose Intolerance, Diabetes, Acanthosis Nigricans
- Medical subject headings
- Obesity, Glucose Intolerance, Diabetes Mellitus, Acanthosis Nigricans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000112
- Sponsor's protocol ID
- NCRR-M01RR06022-0029
- Other IDs
- M01RR006022
- Status last verified
- Dec 2003
- First submitted
- 18 Jan 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Halloun R, Galderisi A, Caprio S, Weiss R. Adipose Tissue Insulin Resistance Is Not Associated With Changes in the Degree of Obesity in Children and Adolescents. J Clin Endocrinol Metab. 2023 Apr 13;108(5):1053-1060. doi: 10.1210/clinem/dgac700.
PubMed 36469736Halloun R, Galderisi A, Caprio S, Weiss R. Lack of Evidence for a Causal Role of Hyperinsulinemia in the Progression of Obesity in Children and Adolescents: A Longitudinal Study. Diabetes Care. 2022 Jun 2;45(6):1400-1407. doi: 10.2337/dc21-2210.
PubMed 35235641Ricke J, Klumpen HJ, Amthauer H, Bargellini I, Bartenstein P, de Toni EN, Gasbarrini A, Pech M, Peck-Radosavljevic M, Popovic P, Rosmorduc O, Schott E, Seidensticker M, Verslype C, Sangro B, Malfertheiner P. Impact of combined selective internal radiation therapy and sorafenib on survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Dec;71(6):1164-1174. doi: 10.1016/j.jhep.2019.08.006. Epub 2019 Aug 14.
PubMed 31421157
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Carbohydrate Intolerance in Lean and Obese Children
- ClinicalTrials.gov ID
- NCT00000112
- Acronym / sponsor ID
- NCRR-M01RR06022-0029
- Conditions
- Obesity, Glucose Intolerance, Diabetes, Acanthosis Nigricans
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 19 Jan 2000 (estimated)
- 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 prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is more than just a cosmetic problem, having substantial metabolic consequences. Insulin resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and obese children with acanthosis nigricans with or without a family history of diabetes mellitus will be studied.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obesity: BM +/- 95% for age general good health
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 36469736Halloun R, Galderisi A, Caprio S, Weiss R. Adipose Tissue Insulin Resistance Is Not Associated With Changes in the Degree of Obesity in Children and Adolescents. J Clin Endocrinol Metab. 2023 Apr 13;108(5):1053-1060. doi: 10.1210/clinem/dgac700.
- Derived from this study: PubMed 35235641Halloun R, Galderisi A, Caprio S, Weiss R. Lack of Evidence for a Causal Role of Hyperinsulinemia in the Progression of Obesity in Children and Adolescents: A Longitudinal Study. Diabetes Care. 2022 Jun 2;45(6):1400-1407. doi: 10.2337/dc21-2210.
- Derived from this study: PubMed 31421157Ricke J, Klumpen HJ, Amthauer H, Bargellini I, Bartenstein P, de Toni EN, Gasbarrini A, Pech M, Peck-Radosavljevic M, Popovic P, Rosmorduc O, Schott E, Seidensticker M, Verslype C, Sangro B, Malfertheiner P. Impact of combined selective internal radiation therapy and sorafenib on survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Dec;71(6):1164-1174. doi: 10.1016/j.jhep.2019.08.006. Epub 2019 Aug 14.
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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.
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 Glucose Intolerance, run by National Center for Research Resources (NCRR) 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Caprio, M.D. (1-203-764-5692, sonia.caprio@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000112, which also lists 3 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 24 Jun 2005.