The Role of Amylin and Glucagon in T1DM
|ClinicalTrials.gov Identifier: NCT00206258|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 14, 2016
|First Submitted Date ICMJE||September 12, 2005|
|First Posted Date ICMJE||September 21, 2005|
|Last Update Posted Date||July 14, 2016|
|Study Start Date ICMJE||July 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Area under the curve for glucose|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00206258 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Glucagon and gastric emptying|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Role of Amylin and Glucagon in T1DM|
|Official Title ICMJE||The Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes|
|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.|
Objective: To develop a new treatment approach in the prevention of hypo and hyperglycemia in children with type 1diabetes.
Background/Rationale: 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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Type 1 Diabetes|
|Intervention ICMJE||Drug: Pramlintide and glucagon|
|Study Arms||Not Provided|
|Publications *||Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||August 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||12 Years to 21 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00206258|
|Other Study ID Numbers ICMJE||H-11741|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Sponsored Programs, Baylor College of Medicine|
|Study Sponsor ICMJE||Baylor College of Medicine|
|Collaborators ICMJE||Not Provided|
|PRS Account||Baylor College of Medicine|
|Verification Date||July 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP