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Diagnostic Test

Glucose Tolerance Testing for Diabetes Risk in Children

N/A

Waitlist Available

Led By Sonia Caprio, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 7-21

Be younger than 65 years old

Must not have

Children previously treated for another endocrinopathy

Children on chronic medications known to alter glucose or insulin metabolism, such as oral steroids, Xeleca, Lithium, and Paxil

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed at baseline measurement

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how common diabetes is in children who are either skinny with a family history of diabetes, or overweight/obese with or without a family history of diabetes.

Who is the study for?

This trial is for children aged 7-21 who either have a family history of type 2 diabetes or are overweight/obese. It's not open to kids on certain meds that affect blood sugar, those with other hormonal disorders, or those treated with steroids, antirejection drugs, or chemotherapy.

What is being tested?

The study aims to find out how common carbohydrate intolerance is in lean and overweight/obese kids by using an Oral Glucose Tolerance Test (OGTT). This test involves drinking a sugary solution and measuring blood sugar levels at intervals.

What are the potential side effects?

An OGTT can cause side effects like feeling sick, bloated, lightheadedness due to fasting before the test and the sudden intake of glucose. Some may also experience low blood sugar after the test.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 7 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child was treated for a hormone-related condition before.

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My child takes medication that can change sugar or insulin levels, like steroids or Paxil.

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My BMI is below the 85th percentile for my age and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline measurements

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline measurements

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline measurements for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose Tolerance

Secondary study objectives

Insulin resistance

Other study objectives

Gene Expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Obese/overweight chldren/adolescentsExperimental Treatment1 Intervention

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.

Group II: Lean children/adolescentsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral Glucose tolerance test

2015

N/A

~2520

0 / 4Eligibility criteria met