Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360373
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2006-08-02
Brief Title:
Adolescent Gastric By-pass and Diabetic Precursors
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Adolescent Gastric By-pass and Diabetic Precursors
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 US 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 kgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK068228 | NIH | None | httpsreporternihgovquickSearchR03DK068228 |