The Effects of Puberty and Weight on Sugar Metabolism in Children

The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia

Our goal is to investigate how hormones that control blood sugar, hunger, and stomach emptying change with puberty and being overweight. These substances change with a meal.

• For this, we need to compare lean and overweight children.
• We need to study them before and during puberty.
• All children in the study will be tested before and after a liquid meal.

Study Overview

• Status: Completed
• Conditions: Adolescent; Overweight; Leanness

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prepubertal and pubertal subjects.

Description

Inclusion Criteria:

All groups:

Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.

Exclusion Criteria:

Same for all groups

The subjects will be excluded if they have:

• a history of chronic disease
• allergy to acetaminophen
• evidence or history of chemical abuse
• abnormal lab values
• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Group A; Healthy lean children before puberty
Group B; Otherwise healthy overweight children before puberty
Group C; Healthy lean adolescents in mid to late puberty
Group D; Otherwise healthy overweight adolescents in mid to late puberty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overweight and Lean Children Sugar Metabolism Before and During Puberty	Too much weight gain can cause changes in the substances that control blood sugar and hunger in the body. Scientists need to compare these substances in lean and overweight children before and during puberty. These substances can be measured before and after a meal in the blood and in the urine. The way your stomach moves food can change your sugar levels. We want to understand how diabetes develops by studying these things. This can help find better ways to prevent and treat diabetes.	4 hours

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Luisa M. Rodriguez, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: H-29652; NIH 1K126K63691 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No