The Effects of Puberty and Weight on Sugar Metabolism in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Luisa M. Rodriguez, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01718080
First received: October 29, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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 Baylor College of Medicine:

Primary Outcome Measures:
  • Overweight and Lean Children Sugar Metabolism Before and During Puberty [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 64
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718080

Contacts
Contact: Kathy Shippy, RN, CCRP 832-824-1268 klshippy@texaschildrens.org

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

No publications provided

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
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Obese, Lean, Pubertal, Prepubertal, Glucose Metabolism, Children, Adolescents, Type 2 Diabetes Prevention

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014