OverweightNCT01718080
The Effects of Puberty and Weight on Sugar Metabolism in Children
An observational study of Overweight and Leanness, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Leanness, Adolescent
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Prepubertal and pubertal subjects.
Who may be able to join
- All groups:
- Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight, Leanness, Adolescent
- Keywords
- Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes
- Medical subject headings
- Overweight, Thinness, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa M. Rodriguez, Baylor College of Medicine
- Investigators
- Luisa M. Rodriguez, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718080
- Sponsor's protocol ID
- H-29652
- Other IDs
- NIH 1K126K63691
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Puberty and Insulin Resistance in the Development of Hyperglucagonemia
- ClinicalTrials.gov ID
- NCT01718080
- Acronym / sponsor ID
- H-29652
- Conditions
- Overweight, Leanness, Adolescent
- Keywords
- Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Prepubertal and pubertal subjects.
Key inclusion criteria (2 listed)
- Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.
Key exclusion criteria (7 listed)
- Same for all groups
- a history of chronic disease
- allergy to acetaminophen
- evidence or history of chemical abuse
- abnormal lab values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa M. Rodriguez, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Leanness, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overweight and Lean Children Sugar Metabolism Before and During Puberty (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.