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The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus
The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible. In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes. There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars. Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin. Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.
Age
12 - 21 years
Sex
ALL
Healthy Volunteers
No
Baylor College of Medicine
Houston, Texas, United States
Start Date
July 1, 2009
Primary Completion Date
May 1, 2011
Completion Date
May 1, 2011
Last Updated
April 24, 2017
16
ACTUAL participants
Byetta (exenatide)
DRUG
Symlin (pramlintide)
DRUG
Lead Sponsor
Baylor College of Medicine
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587