Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105352
Status:
COMPLETED
Last Update Posted:
2016-06-02
First Post:
2005-03-11
Brief Title:
Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials
Status:
COMPLETED
Status Verified Date:
2016-06
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:
OBJECTIVE
This study is being conducted by the Type 1 Diabetes TrialNet Study Group funded by the National Institutes of Health in collaboration with the European C-Peptide Group The goal is to evaluate comparability and reproducibility of measures of beta cell function in type 1 diabetes comparing the mixed meal tolerance tests MMTT and glucagon stimulation test GST These two tests will be compared to assess the relationship between the MMTT and IV intravenous Glucagon stimulated C-peptide responses as measured by time to peak C-peptide and AUC area under the curve values
Based on the understanding that type 1 diabetes results from an immune mediated loss of pancreatic beta cells therapeutic trials and newer measures of beta cell function can be evaluated as endpoints for clinical trials Direct assessment of residual beta cell function is an appropriate endpoint as retention of beta cell function in patients with T1D is known to result in improved glycemic control and reduced hypoglycemia retinopathy and nephropathy Endogenous beta cell function or insulin secretion is best measured by determination of C-peptide which is co-secreted with insulin in a 11 molar ratio Intervention studies over the past few decades have usually used measurement of C-peptide However the relationship between these or other measures of beta cell function has not been well studied The relative advantages of one measure over another in terms of variability sensitivity and burden to the subject is unknown In addition the optimal conditions for the conduct of the test need to be determined
An important goal is to develop an international consensus about the conduct of metabolic tests in the context of large multicenter trials involving type 1 diabetes T1D by balancing the scientific data with the burden on the subject
This study is being conducted by the Type 1 Diabetes TrialNet Study Group funded by the National Institutes of Health in collaboration with the European C-Peptide Group The goal is to evaluate comparability and reproducibility of measures of beta cell function in type 1 diabetes comparing the mixed meal tolerance tests MMTT and glucagon stimulation test GST These two tests will be compared to assess the relationship between the MMTT and IV intravenous Glucagon stimulated C-peptide responses as measured by time to peak C-peptide and AUC area under the curve values
Based on the understanding that type 1 diabetes results from an immune mediated loss of pancreatic beta cells therapeutic trials and newer measures of beta cell function can be evaluated as endpoints for clinical trials Direct assessment of residual beta cell function is an appropriate endpoint as retention of beta cell function in patients with T1D is known to result in improved glycemic control and reduced hypoglycemia retinopathy and nephropathy Endogenous beta cell function or insulin secretion is best measured by determination of C-peptide which is co-secreted with insulin in a 11 molar ratio Intervention studies over the past few decades have usually used measurement of C-peptide However the relationship between these or other measures of beta cell function has not been well studied The relative advantages of one measure over another in terms of variability sensitivity and burden to the subject is unknown In addition the optimal conditions for the conduct of the test need to be determined
An important goal is to develop an international consensus about the conduct of metabolic tests in the context of large multicenter trials involving type 1 diabetes T1D by balancing the scientific data with the burden on the subject
Detailed Description:
Overview
The study is a multi-center two-arm randomized clinical trial Each participant will undergo four tests within a limited period according to the test sequence assignment The tests will randomly start with either MMTT or GST
Specific Aims
To compare the reliability of the MMTT and Glucagon stimulated C-peptide responses as measured by time to peak C-peptide on MMTT and the peak and AUC values on both tests
To determine the relationship between MMTT and Glucagon stimulated C-peptide responses as measured by time to peak C-peptide on MMTT and peak and AUC values on both tests
To determine the impact of basal glucose peak glucose age of participant time from diagnosis and basal C-peptide with respect to the reliability of measures and relationship between MMTT and Glucagon results
Describe the palatability of patient compliance with and adverse effects of each test MMTT vs GST and to compare the participant and investigator burden to conduct the MMTT and Glucagon tests
TEST INFORMATION
Mixed Meal Tolerance Test MMTT
BOOST is a liquid meal like a milkshake containing a standard amount of fat protein and carbohydrate BOOST raises blood sugar and causes the pancreas to produce insulin After drinking BOOST about one-half teaspoon of blood will be drawn through an IV line in the arm after 15 30 60 90 and 120 minutes Using an IV line avoids multiple needle sticks The test takes about 2 hours
Glucagon Stimulation Test GST
Glucagon is a hormone that circulates in the blood and stimulates insulin secretion Glucagon will be injected into the bloodstream through an IV line and about one-half teaspoon of blood will be drawn five times during ten minutes The test takes about 30 minutes
OTHER TEST INFORMATION
Participants will have tests on four different days over a six week period Participants will have either a two MMTTs and then two GSTs OR b two GSTs and then two MMTTs Each test will be done 3-10 days apart
Participants will follow a special high carbohydrate diet 150 grams for at least three days prior to each study visit Dietary information will be provided
Participants will fast overnight at least 8 hours and arrive at the clinic between 7 AM - 10 AM
It is essential that participants have a blood glucose level of 70-200 mgdl in the morning before starting the test If blood glucose is too high or too low the morning of the test the test will be re-scheduled on another day
Tests will be re-scheduled if on the morning of the test your blood sugar or ketones are not within acceptable ranges Testing could take up to eight visits if tests need to be re-scheduled
Participants will learn whether their pancreas is still secreting insulin and if so how much insulin is being secreted This information may help their diabetes health care team design for them a better insulin regimen and diabetes management program to improve their longterm blood sugar control
This study will help researchers learn which test MMTT or GST is best to use in other research studies looking at treatments that may stop or delay type 1 diabetes
The study is a multi-center two-arm randomized clinical trial Each participant will undergo four tests within a limited period according to the test sequence assignment The tests will randomly start with either MMTT or GST
Specific Aims
To compare the reliability of the MMTT and Glucagon stimulated C-peptide responses as measured by time to peak C-peptide on MMTT and the peak and AUC values on both tests
To determine the relationship between MMTT and Glucagon stimulated C-peptide responses as measured by time to peak C-peptide on MMTT and peak and AUC values on both tests
To determine the impact of basal glucose peak glucose age of participant time from diagnosis and basal C-peptide with respect to the reliability of measures and relationship between MMTT and Glucagon results
Describe the palatability of patient compliance with and adverse effects of each test MMTT vs GST and to compare the participant and investigator burden to conduct the MMTT and Glucagon tests
TEST INFORMATION
Mixed Meal Tolerance Test MMTT
BOOST is a liquid meal like a milkshake containing a standard amount of fat protein and carbohydrate BOOST raises blood sugar and causes the pancreas to produce insulin After drinking BOOST about one-half teaspoon of blood will be drawn through an IV line in the arm after 15 30 60 90 and 120 minutes Using an IV line avoids multiple needle sticks The test takes about 2 hours
Glucagon Stimulation Test GST
Glucagon is a hormone that circulates in the blood and stimulates insulin secretion Glucagon will be injected into the bloodstream through an IV line and about one-half teaspoon of blood will be drawn five times during ten minutes The test takes about 30 minutes
OTHER TEST INFORMATION
Participants will have tests on four different days over a six week period Participants will have either a two MMTTs and then two GSTs OR b two GSTs and then two MMTTs Each test will be done 3-10 days apart
Participants will follow a special high carbohydrate diet 150 grams for at least three days prior to each study visit Dietary information will be provided
Participants will fast overnight at least 8 hours and arrive at the clinic between 7 AM - 10 AM
It is essential that participants have a blood glucose level of 70-200 mgdl in the morning before starting the test If blood glucose is too high or too low the morning of the test the test will be re-scheduled on another day
Tests will be re-scheduled if on the morning of the test your blood sugar or ketones are not within acceptable ranges Testing could take up to eight visits if tests need to be re-scheduled
Participants will learn whether their pancreas is still secreting insulin and if so how much insulin is being secreted This information may help their diabetes health care team design for them a better insulin regimen and diabetes management program to improve their longterm blood sugar control
This study will help researchers learn which test MMTT or GST is best to use in other research studies looking at treatments that may stop or delay type 1 diabetes
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