ObesityNCT00360373
Adolescent Gastric By-pass and Diabetic Precursors
An observational study of Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to find out what effects (good and bad) gastric bypass has on metabolism, including pancreatic insulin secretion. In addition, we will compare the effects of gastric bypass on the metabolism of adults and adolescents to try to determine whether there are greater metabolic and… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Obesity
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Feb 2012
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents undergoing weight loss surgery
Who may be able to join
- Approved to be scheduled for laparoscopic gastric bypass surgery for VSO at Cincinnati Children's or University Hospital
- Age at time of gastric bypass surgery date >15 and <21 years, or >30 and <45 years
- BMI >40
- Weight at age 18 consistent with severe adolescent obesity (if height < 5'5" weight > 200 pounds or if height >5'5", weight > 250)
Who cannot join
- Diagnosis of cirrhosis, total bilirubin >1 mg/dL, prothrombin time > 13.3 sec
- Prior myocardial infarction
- Serum creatinine >1.7mg/dL
- Systemic (PO, IV, IM) glucocorticoid therapy within the previous six weeks prior to blood sampling
- Peri-menopausal (irregularity of menstrual periods over the past 3 months (67) or demonstrated abnormally high follicle stimulating hormone levels (68)
- Severe T2DM (on insulin for control of hyperglycemia, or HbA1c > 8.5)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this research study is to find out what effects (good and bad) gastric bypass has on metabolism, including pancreatic insulin secretion. In addition, we will compare the effects of gastric bypass on the metabolism of adults and adolescents to try to determine whether there are greater metabolic and health advantages of performing gastric bypass earlier in life versus waiting until adulthood.
Read the detailed description
Overweight and obesity are the most common metabolic disorders affecting the U.S. with 31% of adults and 16% of adolescents now meeting Centers for Disease Control criteria for these conditions. As the obesity epidemic has unfolded, so too has the increase in prevalence of abnormalities of carbohydrate metabolism. The single most effective treatment for type 2 diabetes in severely obese adults may be bariatric surgery, a procedure that is most commonly performed in the 5th and 6th decades of life. While it is clear that rapid and profound weight loss can significantly improve carbohydrate metabolism in adults, it is not clear to what degree type 2 diabetes is reversible in these patients. The pathophysiology of type 2 diabetes in adolescents and children is not well understood and no studies have yet examined the effect of surgical weight loss on insulin resistance, insulin secretion, or glucose tolerance in severely obese young people. However, it seems likely that bariatric surgery could improve these conditions in youth. Understanding the relative benefits of surgically induced weight reduction on carbohydrate metabolism in adolescents compared to older subjects is important for determining optimal timing of this intervention. This knowledge may also lead to key insights into obesity-induced diabetes. In this project we will test the hypothesis that bariatric surgical intervention will more effectively improve insulin resistance, β cell dysfunction, and glucose tolerance in adolescents compared to adults. Three specific aims are proposed: 1) To compare the derangements of carbohydrate metabolism among very severely obese (body mass index ≥ 40 kg/m2) adolescents and adults referred for bariatric surgery; 2) To assess improvement in carbohydrate metabolism longitudinally (during and after surgical weight loss) comparing differences in the mechanisms of improvement between the two age groups; 3) To compare major complications in the two age groups following bariatric surgery. These data will provide critical information about age-related metabolic outcomes of bariatric surgery and could inform the design of larger studies to examine the role of early bariatric surgery in management of disorders related to insulin resistance in patients at high risk for these conditions.
- Conditions
- Obesity
- Keywords
- bariatric, obesity, insulin resistance, gastric bypass, adolescent
- Medical subject headings
- Obesity, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
This study uses the frequently sampled intravenous glucose tolerance test (FSIVGTT) to determine the effects of bariatric surgery on insulin resistance, carbohydrate metabolism, β cell dysfunction, and glucose tolerance for this adolescent cohort. Carbohydrate metabolism will be assessed by measuring plasma glucose and insulin concentrations in blood samples obtained during fasting as well as during FSIVGTT at baseline and all subsequent time points..
Measured: 2 weeks, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionMar 2009
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Inge, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360373
- Sponsor's protocol ID
- DK68228
- Other IDs
- R03DK068228
- Status last verified
- Jan 2014
- First submitted
- 2 Aug 2006
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeffreys RM, Hrovat K, Woo JG, Schmidt M, Inge TH, Xanthakos SA. Dietary assessment of adolescents undergoing laparoscopic Roux-en-Y gastric bypass surgery: macro- and micronutrient, fiber, and supplement intake. Surg Obes Relat Dis. 2012 May-Jun;8(3):331-6. doi: 10.1016/j.soard.2011.11.016. Epub 2011 Dec 10.
PubMed 22260884Inge TH, Prigeon RL, Elder DA, Jenkins TM, Cohen RM, Xanthakos SA, Benoit SC, Dolan LM, Daniels SR, D'Alessio DA. Insulin Sensitivity and beta-Cell Function Improve after Gastric Bypass in Severely Obese Adolescents. J Pediatr. 2015 Nov;167(5):1042-8.e1. doi: 10.1016/j.jpeds.2015.08.020. Epub 2015 Sep 9.
PubMed 26363548
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Gastric By-pass and Diabetic Precursors
- ClinicalTrials.gov ID
- NCT00360373
- Acronym / sponsor ID
- DK68228
- Conditions
- Obesity
- Keywords
- bariatric, obesity, insulin resistance, gastric bypass, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Aug 2006 (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.
The purpose of this research study is to find out what effects (good and bad) gastric bypass has on metabolism, including pancreatic insulin secretion. In addition, we will compare the effects of gastric bypass on the metabolism of adults and adolescents to try to determine whether there are greater metabolic and health advantages of performing gastric bypass earlier in life versus waiting until adulthood.
Detailed description
Overweight and obesity are the most common metabolic disorders affecting the U.S. with 31% of adults and 16% of adolescents now meeting Centers for Disease Control criteria for these conditions. As the obesity epidemic has unfolded, so too has the increase in prevalence of abnormalities of carbohydrate metabolism. The single most effective treatment for type 2 diabetes in severely obese adults may be bariatric surgery, a procedure that is most commonly performed in the 5th and 6th decades of life. While it is clear that rapid and profound weight loss can significantly improve carbohydrate metabolism in adults, it is not clear to what degree type 2 diabetes is reversible in these patients. The pathophysiology of type 2 diabetes in adolescents and children is not well understood and no studies have yet examined the effect of surgical weight loss on insulin resistance, insulin secretion, or glucose tolerance in severely obese young people. However, it seems likely that bariatric surgery could improve these conditions in youth. Understanding the relative benefits of surgically induced weight reduction on carbohydrate metabolism in adolescents compared to older subjects is important for determining optimal timing of this intervention. This knowledge may also lead to key insights into obesity-induced diabetes. In this project we will test the hypothesis that bariatric surgical intervention will more effectively improve insulin resistance, β cell dysfunction, and glucose tolerance in adolescents compared to adults. Three specific aims are proposed: 1) To compare the derangements of carbohydrate metabolism among very severely obese (body mass index ≥ 40 kg/m2) adolescents and adults referred for bariatric surgery; 2) To assess improvement in carbohydrate metabolism longitudinally (during and after surgical weight loss) comparing differences in the mechanisms of improvement between the two age groups; 3) To compare major complications in the two age groups following bariatric surgery. These data will provide critical information about age-related metabolic outcomes of bariatric surgery and could inform the design of larger studies to examine the role of early bariatric surgery in management of disorders related to insulin resistance in patients at high risk for these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents undergoing weight loss surgery
Key inclusion criteria (4 listed)
- Approved to be scheduled for laparoscopic gastric bypass surgery for VSO at Cincinnati Children's or University Hospital
- Age at time of gastric bypass surgery date >15 and <21 years, or >30 and <45 years
- BMI >40
- Weight at age 18 consistent with severe adolescent obesity (if height < 5'5" weight > 200 pounds or if height >5'5", weight > 250)
Key exclusion criteria (6 listed)
- Diagnosis of cirrhosis, total bilirubin >1 mg/dL, prothrombin time > 13.3 sec
- Prior myocardial infarction
- Serum creatinine >1.7mg/dL
- Systemic (PO, IV, IM) glucocorticoid therapy within the previous six weeks prior to blood sampling
- Peri-menopausal (irregularity of menstrual periods over the past 3 months (67) or demonstrated abnormally high follicle stimulating hormone levels (68)
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
Insulin Resistance
Time frame: 2 weeks, 3 months, and 12 months
This study uses the frequently sampled intravenous glucose tolerance test (FSIVGTT) to determine the effects of bariatric surgery on insulin resistance, carbohydrate metabolism, β cell dysfunction, and glucose tolerance for this adolescent cohort. Carbohydrate metabolism will be assessed by measuring plasma glucose and insulin concentrations in blood samples obtained during fasting as well as during FSIVGTT at baseline and all subsequent time points..
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 6 Jan 2014.
- Results publication: PubMed 22260884Jeffreys RM, Hrovat K, Woo JG, Schmidt M, Inge TH, Xanthakos SA. Dietary assessment of adolescents undergoing laparoscopic Roux-en-Y gastric bypass surgery: macro- and micronutrient, fiber, and supplement intake. Surg Obes Relat Dis. 2012 May-Jun;8(3):331-6. doi: 10.1016/j.soard.2011.11.016. Epub 2011 Dec 10.
- Derived from this study: PubMed 26363548Inge TH, Prigeon RL, Elder DA, Jenkins TM, Cohen RM, Xanthakos SA, Benoit SC, Dolan LM, Daniels SR, D'Alessio DA. Insulin Sensitivity and beta-Cell Function Improve after Gastric Bypass in Severely Obese Adolescents. J Pediatr. 2015 Nov;167(5):1042-8.e1. doi: 10.1016/j.jpeds.2015.08.020. Epub 2015 Sep 9.
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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.
Thomas H Inge, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Obesity, run by Children's Hospital Medical Center, Cincinnati 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 4 inclusion and 6 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 6 Jan 2014. 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?
Insulin Resistance (time frame: 2 weeks, 3 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360373, which also lists 2 linked publications.
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 6 Jan 2014.