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| Sponsored by: |
Baylor College of Medicine |
|---|---|
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00206297 |
Purpose
The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Drug: Pramlintide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | February 2006 |
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 insulin management is aimed to control blood sugar and glycosylated hemoglobin (3 month blood glucose average test) as near to normal as safely possible. However, hypoglycemia (low blood sugar) was increased three fold in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar in T1DM.
In healthy individuals, an "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in maintaining this careful balance. In T1DM, there is a lack of insulin and failure of glucagon suppression (keeping glucagon from being made too much). This leads to hyperglycemia (high blood sugar) right after you eat food. Also, glucagon is not controlled correctly after a meal. The glucagon, normally produced by the body, does not increase when a person with T1DM has a low blood sugar. This interferes with the balance between how much glucose is made and how much glucose is used. Therefore, glucagon fails to protect against low blood sugar in people with T1DM. This makes it very difficult to have normal blood sugars when someone has T1DM. This imbalance may be due to another hormone called amylin. This hormone may be too low in people with T1DM.
Amylin is produced in the pancreas (the part of the body that makes insulin) by the same cells that produce insulin and is also lacking in persons with T1DM. Amylin works by lowering glucagon after a meal. This keeps the liver from letting out stored sugar into the blood stream right after we eat. Pramlintide is man-made amylin and is given as a subcutaneous shot (under the skin) similar to insulin. At present, pramlintide has not received FDA approval.
Studies performed in adults have shown that adding amylin in T1DM, using pramlintide, lowers the high levels of glucagon made after a meal. This results in improved "after meal" high blood sugars and overall blood sugar control. Currently, pramlintide in adults is given as a separate injection from insulin, before meals, three times a day. When given as a bolus shot (one dose shot given all at once) to children and young adults, it seems to cause immediate low blood sugars after a meal. The low blood sugars may be caused by the "slowing down" of food digestion by pramlintide. Another possible cause of the low blood sugars may be the way pramlintide is being given (bolus shot versus a dual wave infusion).
Eligibility| Ages Eligible for Study: | 12 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Rubina Heptulla, MD | Baylor College of Medicine |
More Information
| Study ID Numbers: | H-14358 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 19, 2006 |
| ClinicalTrials.gov Identifier: | NCT00206297 |
| Health Authority: | United States: Food and Drug Administration |
|
Type 1 diabetes hypoglycemia hyperglycemia |
|
Autoimmune Diseases Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Pramlintide Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia |
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Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |
