Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01967849 |
Recruitment Status :
Recruiting
First Posted : October 23, 2013
Last Update Posted : September 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Type 2 Diabetes | Diagnostic Test: Oral Glucose tolerance test | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children |
Study Start Date : | September 1999 |
Estimated Primary Completion Date : | September 2025 |
Estimated Study Completion Date : | September 2025 |

Arm | Intervention/treatment |
---|---|
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.
|
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.
|
Diagnostic Test: Oral Glucose tolerance test |
- Glucose Tolerance [ Time Frame: Baseline measurements ]Glucose tolerance status as determined by 3 hour oral glucose tolerance test
- Insulin resistance [ Time Frame: Completed at baseline measurement ]Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)
- Gene Expression [ Time Frame: Completed at baseline measurement ]Gene mutation/allelle variation identification measured via gene extraction

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ages 7-21
- family history of type 2 diabetes mellitus
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967849
Contact: Melissa M Shaw | 2037856459 | melissa.m.shaw@yale.edu |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Sonia Caprio, MD 203-764-9199 |
Principal Investigator: | Sonia Caprio, MD | Yale Pediatric Endocrinology |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01967849 |
Other Study ID Numbers: |
9909011190 R01HD040787 ( U.S. NIH Grant/Contract ) 1R01DK111038-01A1 ( U.S. NIH Grant/Contract ) 2R01HD028016-20A1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 23, 2013 Key Record Dates |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
obesity type 2 diabetes |
Diabetes Mellitus, Type 2 Overweight Body Weight Diabetes Mellitus |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |