ObesityNCT01967849
Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
An observational study of Obesity and Type 2 Diabetes, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and in overweight/obese children with or without a family history of diabetes mellitus. Read more about this study
- Who is it for?
- Ages 7 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Oral Glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to 18 Sep 2023
- 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 7 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Primarily these patients are recruited from Yale Pediatric Endocrinology Clinic or are siblings of patients.
Who may be able to join
- ages 7-21
- family history of type 2 diabetes mellitus
Who cannot join
- Children will be excluded if they have previously been treated for another endocrinopathy or are on any chronic medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil.
- Lean (not overweight or obese) will be defined as a body mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender, overweight will be defined as a BMI between the 85th and 95th percentiles, and obesity will be defined as a BMI greater than the 95th percentile.
- Children will be excluded from participating in the genetic analysis if they are treated oral glucocorticoids or antirejection or chemotherapy (e.g. tacrolimus, Lasparaginase.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and in overweight/obese children with or without a family history of diabetes mellitus.
Read the detailed description
The patient participates in the study for a total duration of approximately four hours. The study nurse will do a nursing assessment, including measuring the patient's height, weight, waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean mass may also be measured using a Tanita scale. The nurse will obtain a family and medical history from the patient and/or the patient's parent/guardian. In addition, before starting the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the patient for analysis of microalbumin and creatinine.
The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola). The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10 times over three hours. Should abnormal glucose results be found, appropriate referrals will be made. We will draw approximately 80 cc of blood during this study. The blood will be analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as well as an optional 10 cc sample to be stored for future undetermined analysis.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Oral Glucose tolerance test
- Keywords
- obesity, type 2 diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose tolerance testDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Obese/overweight chldren/adolescents | Obese or overweight children and adolescents between ages 7-21 that are at risk for developing type 2 diabetes will undergo an Oral Glucose Tolerance test (OGTT) to asses glucose status. Receives: Diagnostic Test: Oral Glucose tolerance test | |
| Lean children/adolescents | Lean children/adolescents between the ages of 7-21. This cohort should have family members that have type 2 diabetes or was the result of a gestational diabetes pregnancy. They will undergo an Oral Glucose Tolerance Test to assess glucose status. Receives: Diagnostic Test: Oral Glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
Glucose tolerance status as determined by 3 hour oral glucose tolerance test
Measured: Baseline measurements
Secondary outcomes (1)
Insulin resistance
Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)
Measured: Completed at baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startSep 1999
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967849
- Sponsor's protocol ID
- 9909011190
- Other IDs
- R01HD040787, 1R01DK111038-01A1, 2R01HD028016-20A1
- Status last verified
- Sep 2024
- First submitted
- 15 Jul 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Trico D, McCollum S, Samuels S, Santoro N, Galderisi A, Groop L, Caprio S, Shabanova V. Mechanistic Insights Into the Heterogeneity of Glucose Response Classes in Youths With Obesity: A Latent Class Trajectory Approach. Diabetes Care. 2022 Aug 1;45(8):1841-1851. doi: 10.2337/dc22-0110.
PubMed 35766976Halloun 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 35235641Zabarsky G, Beek C, Hagman E, Pierpont B, Caprio S, Weiss R. Impact of Severe Obesity on Cardiovascular Risk Factors in Youth. J Pediatr. 2018 Jan;192:105-114. doi: 10.1016/j.jpeds.2017.09.066.
PubMed 29246331Hershkop K, Besor O, Santoro N, Pierpont B, Caprio S, Weiss R. Adipose Insulin Resistance in Obese Adolescents Across the Spectrum of Glucose Tolerance. J Clin Endocrinol Metab. 2016 Jun;101(6):2423-31. doi: 10.1210/jc.2016-1376. Epub 2016 Apr 7.
PubMed 27054297
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT01967849
- Acronym / sponsor ID
- 9909011190
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- obesity, type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 1999 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 23 Oct 2013 (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 purpose of this study is to determine the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and in overweight/obese children with or without a family history of diabetes mellitus.
Detailed description
The patient participates in the study for a total duration of approximately four hours. The study nurse will do a nursing assessment, including measuring the patient's height, weight, waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean mass may also be measured using a Tanita scale. The nurse will obtain a family and medical history from the patient and/or the patient's parent/guardian. In addition, before starting the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the patient for analysis of microalbumin and creatinine.
The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola). The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10 times over three hours. Should abnormal glucose results be found, appropriate referrals will be made. We will draw approximately 80 cc of blood during this study. The blood will be analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as well as an optional 10 cc sample to be stored for future undetermined analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese/overweight chldren/adolescents | – | Diagnostic Test: Oral Glucose tolerance testObese or overweight children and adolescents between ages 7-21 that are at risk for developing type 2 diabetes will undergo an Oral Glucose Tolerance test (OGTT) to asses glucose status. |
| Lean children/adolescents | – | Diagnostic Test: Oral Glucose tolerance testLean children/adolescents between the ages of 7-21. This cohort should have family members that have type 2 diabetes or was the result of a gestational diabetes pregnancy. They will undergo an Oral Glucose Tolerance Test to assess glucose status. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Primarily these patients are recruited from Yale Pediatric Endocrinology Clinic or are siblings of patients.
Key inclusion criteria (2 listed)
- ages 7-21
- family history of type 2 diabetes mellitus
Key exclusion criteria (3 listed)
- Children will be excluded if they have previously been treated for another endocrinopathy or are on any chronic medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil.
- Lean (not overweight or obese) will be defined as a body mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender, overweight will be defined as a BMI between the 85th and 95th percentiles, and obesity will be defined as a BMI greater than the 95th percentile.
- Children will be excluded from participating in the genetic analysis if they are treated oral glucocorticoids or antirejection or chemotherapy (e.g. tacrolimus, Lasparaginase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose tolerance test | Diagnostic test | Lean children/adolescents, Obese/overweight chldren/adolescents |
Primary outcome
Glucose Tolerance
Time frame: Baseline measurements
Glucose tolerance status as determined by 3 hour oral glucose tolerance test
1 secondary outcome
Insulin resistance
Time frame: Completed at baseline measurement
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 19 Sep 2024.
- Derived from this study: PubMed 35766976Trico D, McCollum S, Samuels S, Santoro N, Galderisi A, Groop L, Caprio S, Shabanova V. Mechanistic Insights Into the Heterogeneity of Glucose Response Classes in Youths With Obesity: A Latent Class Trajectory Approach. Diabetes Care. 2022 Aug 1;45(8):1841-1851. doi: 10.2337/dc22-0110.
- 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 29246331Zabarsky G, Beek C, Hagman E, Pierpont B, Caprio S, Weiss R. Impact of Severe Obesity on Cardiovascular Risk Factors in Youth. J Pediatr. 2018 Jan;192:105-114. doi: 10.1016/j.jpeds.2017.09.066.
- Derived from this study: PubMed 27054297Hershkop K, Besor O, Santoro N, Pierpont B, Caprio S, Weiss R. Adipose Insulin Resistance in Obese Adolescents Across the Spectrum of Glucose Tolerance. J Clin Endocrinol Metab. 2016 Jun;101(6):2423-31. doi: 10.1210/jc.2016-1376. Epub 2016 Apr 7.
- Individual participant dataSharing planned: No
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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.
Sonia Caprio, MD principal investigator
Yale Pediatric Endocrinology
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, run by Yale University 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 2 inclusion and 3 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 19 Sep 2024. 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?
Glucose Tolerance (time frame: Baseline measurements). 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 NCT01967849, which also lists 4 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 19 Sep 2024.