Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442767
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2007-03-01
Brief Title:
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs standard therapy of pre-meal insulin on post-prandial glucose excursions
The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes
The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes
Detailed Description:
Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents 6 males 2 females with type 1 diabetes were recruited to the open-labeled non-randomized crossover study Two male subjects were African American the remaining subjects were all Caucasian Six subjects were on insulin pump therapy and the two on insulin glargine self-administered at -90minutes Subjects had their last meal before 12 midnight and stayed at our research center from 7AM until completion of the study at 2PM Study A was done before study B
Basal insulin doses of the subjects were kept constant through studies A and B No subject was prescribed pramlintide any time in the past prior to participation in this study
Study AInsulin therapy was continued as per prescribed home regimen without pramlintide Subjects self-administered a rapid-acting insulin analog aspart or lispro bolus based on their individual insulin carbohydrate ratio following which they received 12oz 591ml of Boost High Protein drink 360 calories 50gms carbohydrate 12 gms fat at 9AM 0 minutes The Boost was consumed in 5 - 7 minutes Blood samples were collected for the analysis of blood glucose BG levels at -60 -30 -10 and 0 minutes and every 10 minutes thereafter for the first hour every 20 minutes for the second hour and every 30 minutes until the study ended Blood samples were also collected throughout the study at multiple time points for the analysis of insulin and glucagon levels Subjects were provided with lunch at 2PM and discharged
Study BThe study protocol was identical to study A except 30mcg of pramlintide was administered subcutaneously immediately prior to drinking the Boost at 9AM and no insulin was given before the meal but was given 15 minutes after the meal 915AM and the dose was reduced by 20 Study B was conducted within 3 to 4 weeks of study A
Basal insulin doses of the subjects were kept constant through studies A and B No subject was prescribed pramlintide any time in the past prior to participation in this study
Study AInsulin therapy was continued as per prescribed home regimen without pramlintide Subjects self-administered a rapid-acting insulin analog aspart or lispro bolus based on their individual insulin carbohydrate ratio following which they received 12oz 591ml of Boost High Protein drink 360 calories 50gms carbohydrate 12 gms fat at 9AM 0 minutes The Boost was consumed in 5 - 7 minutes Blood samples were collected for the analysis of blood glucose BG levels at -60 -30 -10 and 0 minutes and every 10 minutes thereafter for the first hour every 20 minutes for the second hour and every 30 minutes until the study ended Blood samples were also collected throughout the study at multiple time points for the analysis of insulin and glucagon levels Subjects were provided with lunch at 2PM and discharged
Study BThe study protocol was identical to study A except 30mcg of pramlintide was administered subcutaneously immediately prior to drinking the Boost at 9AM and no insulin was given before the meal but was given 15 minutes after the meal 915AM and the dose was reduced by 20 Study B was conducted within 3 to 4 weeks of study A
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCRC protocol 0954 | None | None | None |