Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206258
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2005-09-12
Brief Title:
The Role of Amylin and Glucagon in T1DM
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
The Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar shot given in the late after meal time would prevent low blood sugar The studies outlined in this proposal might help in developing new treatment options to target after meal high blood sugar and before meal low blood sugar in children This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes
Detailed Description:
Objective To develop a new treatment approach in the prevention of hypo and hyperglycemia in children with type 1diabetes
BackgroundRationale The diabetes control and complications trial DCCT showed that improving blood sugar control for individuals with type 1 diabetes T1DM stopped or delayed the onset of long-term complications As a result of the study intensive management to control blood sugar and glycosylated hemoglobin as near to normal as safely as possible is advocated However hypoglycemia was increased 3 fold in the DCCT study and is the major limiting factor in gaining tight control of blood sugar in T1DM
Description of Project In health individuals after meal blood sugar level is very carefully controlled Insulin the hormone that lowers blood sugar and glucagon the hormone that raises blood sugar play a key role in maintaining this careful balance Recently we understand that a hormone called amylin also contributes to this careful after meal blood glucose balance Amylin in the immediate after meal period works by reducing glucagon which in turn reduces the liver releasing stored sugar into the blood stream
In T1DM there is the lack of insulin and failure of glucagon suppression leading to hyperglycemia immediately following when food is eaten Also glucagon is not regulated correctly after a meal The glucagon normally produced by the body does not increase in response to hypoglycemia thus interfering with the delicate balance between glucose production and glucose used Therefore it is difficult to get normal blood sugar when someone has type1 diabetes
Currently the treatment for mild to moderate hypoglycemia causing a sudden feeling of racing heart feeling sweaty weak or hungry is to eat or drink carbohydrate in the awake person Severe hypoglycemia unconsciousness due to low blood sugar is treated with a glucagon shot Unfortunately there are no treatments to prevent mild or severe hypoglycemia
The purpose of this study is to see if giving pramlintide manmade amylin and insulin before a meal would lower hyperglycemia and if a glucagon shot given in the late after meal time would prevent hypoglycemia and allow the blood sugar levels to improve in people with T1DM The studies outlined in this proposal might help in developing new treatment options to target after meal hyperglycemia high blood glucose and before meal hypoglycemia in children This study for the first time will investigate the role of glucagon in the causation of hyperglycemia and its role in the prevention of hypoglycemia
Relevance to Type 1 diabetes Using naturally occurring hormones that are dysregulated or deficient in T1DM we wish to restore normal glucose concentration in T1DM Such treatment if successful would be a major breakthrough in the prevention of hyper and hypoglycemia and in decreasing both short and long-term complications associated with T1DM
BackgroundRationale The diabetes control and complications trial DCCT showed that improving blood sugar control for individuals with type 1 diabetes T1DM stopped or delayed the onset of long-term complications As a result of the study intensive management to control blood sugar and glycosylated hemoglobin as near to normal as safely as possible is advocated However hypoglycemia was increased 3 fold in the DCCT study and is the major limiting factor in gaining tight control of blood sugar in T1DM
Description of Project In health individuals after meal blood sugar level is very carefully controlled Insulin the hormone that lowers blood sugar and glucagon the hormone that raises blood sugar play a key role in maintaining this careful balance Recently we understand that a hormone called amylin also contributes to this careful after meal blood glucose balance Amylin in the immediate after meal period works by reducing glucagon which in turn reduces the liver releasing stored sugar into the blood stream
In T1DM there is the lack of insulin and failure of glucagon suppression leading to hyperglycemia immediately following when food is eaten Also glucagon is not regulated correctly after a meal The glucagon normally produced by the body does not increase in response to hypoglycemia thus interfering with the delicate balance between glucose production and glucose used Therefore it is difficult to get normal blood sugar when someone has type1 diabetes
Currently the treatment for mild to moderate hypoglycemia causing a sudden feeling of racing heart feeling sweaty weak or hungry is to eat or drink carbohydrate in the awake person Severe hypoglycemia unconsciousness due to low blood sugar is treated with a glucagon shot Unfortunately there are no treatments to prevent mild or severe hypoglycemia
The purpose of this study is to see if giving pramlintide manmade amylin and insulin before a meal would lower hyperglycemia and if a glucagon shot given in the late after meal time would prevent hypoglycemia and allow the blood sugar levels to improve in people with T1DM The studies outlined in this proposal might help in developing new treatment options to target after meal hyperglycemia high blood glucose and before meal hypoglycemia in children This study for the first time will investigate the role of glucagon in the causation of hyperglycemia and its role in the prevention of hypoglycemia
Relevance to Type 1 diabetes Using naturally occurring hormones that are dysregulated or deficient in T1DM we wish to restore normal glucose concentration in T1DM Such treatment if successful would be a major breakthrough in the prevention of hyper and hypoglycemia and in decreasing both short and long-term complications associated with T1DM
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