Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

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

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2023-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carbohydrate Counting and DASH Intervention Among Children With Diabetes and Celiac Disease.

NCT05132725

Diabetes Mellitus, Type 1 Celiac Disease in Children

UNKNOWN NA

The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)

NCT02867436

Type 1 Diabetes

COMPLETED NA

BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

NCT01115621

Type 1 Diabetes

UNKNOWN NA

Preservation of Residual Beta Cell Mass and Prevention of Celiac Disease in Children With Recent Onset Type 1 Diabetes

NCT03037190

Diabetes Mellitus, Type 1 Remission Celiac Disease in Children

UNKNOWN NA

Infant Nutrition and Risk of Celiac Disease

NCT00819819

Celiac Disease Infant Nutrition

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Oral Glucose tolerance test

Intervention Type DIAGNOSTIC_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.

Oral Glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes