Viewing Study NCT00361946



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Study NCT ID: NCT00361946
Status: COMPLETED
Last Update Posted: 2017-04-24
First Post: 2006-08-08

Brief Title: The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus T2DM
Sponsor: Baylor College of Medicine
Organization: Baylor College of Medicine

Study Overview

Official Title: The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus T2DM
Status: COMPLETED
Status Verified Date: 2017-04
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: To study postprandial metabolism in lean obese and T2DM adolescents using a mixed meal challenge Specifically we will be measuring the following parameters of postprandial metabolism 1 Postprandial glucose and triglycerides excursions 2 Gastric emptying 3 Insulin amylin glucagon GLP-1 and ghrelin secretion 4 Glucose Turnover rate
Detailed Description: Previously type 2 diabetes mellitus T2DM was considered a disease of the adult however the incidence of T2DM in children is on the rise Consequently complications may occur at an earlier age underscoring the importance of improving glycemic control in the pediatric population Postprandial hyperglycemia contributes significantly to poor glycemic control in T2DM We now understand that in addition to insulin other hormones glucagon amylin and GLP-1 may play a role in the postprandial glucose metabolism The role of gastric emptying has been increasingly recognized as an important factor in regulating glucose appearance into the circulation Abnormalities in the pancreatic hormone amylin and the incretin GLP-1 have emerged as contributors to the alterations in gastric emptying and postprandial hyperglycemia in T2DM Although much is know about the abnormalities related to postprandial hyperglycemia in adults with T2DM little information is available in the pediatric population This protocol will examine gastric emptying glucagon GLP-1 and amylin secretions in healthy lean obese children with and without diabetes post-ingestion of a mixed meal The subject will be age and Tanner stage matched The goal of this project is to better understand the metabolic adaptations of postprandial glucose homeostasis in T2DM by comparing our study group to obese normal glucose tolerance and healthy lean controls The long-term goal for the PI is to use the data gathered with this protocol to develop a K-23 proposal incorporating new therapeutic options through the use of amylin and GLP-1 analogs in children with T2DM to improve postprandial hyperglycemia

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
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
H-17370 OTHER BCM IRB None