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Diagnostic Test
Glucose Tolerance Testing for Diabetes Risk in Children
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at baseline measurement
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 7 and 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline measurements
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline measurements
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose Tolerance
Secondary outcome measures
Insulin resistance
Other outcome measures
Gene Expression
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
~20
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,864 Previous Clinical Trials
2,740,265 Total Patients Enrolled
60 Trials studying Obesity
246,163 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,492,446 Total Patients Enrolled
104 Trials studying Obesity
24,148 Patients Enrolled for Obesity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,678,353 Total Patients Enrolled
105 Trials studying Obesity
100,323 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child was treated for a hormone-related condition before.My child takes medication that can change sugar or insulin levels, like steroids or Paxil.I am between 7 and 21 years old.My child has not been treated with certain medications like oral steroids, tacrolimus, or chemotherapy.My BMI is below the 85th percentile for my age and gender.My family has a history of type 2 diabetes.You are significantly overweight, with a body mass index (BMI) higher than 95% of people your age and gender.You are heavier than most people your age, based on your body mass index (BMI).
Research Study Groups:
This trial has the following groups:- Group 1: Obese/overweight chldren/adolescents
- Group 2: Lean children/adolescents
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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