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The Effects of Puberty and Weight on Sugar Metabolism in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718080
First Posted: October 31, 2012
Last Update Posted: April 24, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Luisa M. Rodriguez, Baylor College of Medicine
  Purpose

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.

Condition
Overweight Leanness Adolescent

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia

Resource links provided by NLM:


Further study details as provided by Luisa M. Rodriguez, Baylor College of Medicine:

Primary Outcome Measures:
  • Overweight and Lean Children Sugar Metabolism Before and During Puberty [ Time Frame: 4 hours ]
    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.


Biospecimen Retention:   Samples Without DNA
plasma

Enrollment: 83
Actual Study Start Date: October 2012
Study Completion Date: June 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prepubertal and pubertal subjects.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01718080


Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Luisa M. Rodriguez, MD Baylor College of Medicine
  More Information

Responsible Party: Luisa M. Rodriguez, The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01718080     History of Changes
Other Study ID Numbers: H-29652
NIH 1K126K63691 ( Other Identifier: NIH )
First Submitted: October 29, 2012
First Posted: October 31, 2012
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luisa M. Rodriguez, Baylor College of Medicine:
Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms