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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00361946 |
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
Condition |
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Type 2 Diabetes |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Random Sample, Prospective Study |
Official Title: | The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM). |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
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.
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luisa M Rodriguez, MD | 832-822-1002 | lrodrigu@bcm.tmc.edu |
Contact: Lori C Malone, MS | 832-822-3784 | lmalone@bcm.tmc.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Luisa M Rodriguez, MD 832-822-1002 lrodrigu@bcm.tmc.edu | |
Contact: Lori C Malone, MS 832-822-3784 lmalone@bcm.tmc.edu | |
Principal Investigator: Luisa M Rodriguez, MD |
Principal Investigator: | Luisa M Rodriguez, MD | Baylor College of Medicine |
Study ID Numbers: | NIH 1K126K63691, H-17370 |
Study First Received: | August 8, 2006 |
Last Updated: | August 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00361946 |
Health Authority: | United States: Institutional Review Board |
Type 2 diabetes Lean Obese |
Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |