The Effects of Puberty and Weight on Sugar Metabolism in Children
The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia
2 other identifiers
observational
83
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 24, 2017
April 1, 2017
2.3 years
October 29, 2012
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
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 Criteria
Prepubertal and pubertal subjects.
You may qualify if:
- All groups:
- Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luisa M. Rodriguez, MD
Baylor College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia
Study Record Dates
First Submitted
October 29, 2012
First Posted
October 31, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2015
Study Completion
June 1, 2015
Last Updated
April 24, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share