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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
October 29, 2012
October 31, 2012
April 24, 2017
October 2012
January 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01718080 on ClinicalTrials.gov Archive Site
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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.
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
plasma
Non-Probability Sample
Prepubertal and pubertal subjects.
  • Overweight
  • Leanness
  • Adolescent
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
June 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01718080
H-29652
NIH 1K126K63691 ( Other Identifier: NIH )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Luisa M. Rodriguez, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Luisa M. Rodriguez, MD Baylor College of Medicine
Baylor College of Medicine
April 2017