Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652867
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-06
Brief Title:
Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event
Status:
COMPLETED
Status Verified Date:
2024-10
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 study aims to obtain a panel of biomarkers from hypoglycemic diabetic patients with either type 1 or type 2 diabetics and from control patients with type 1 or type 2 diabetes who didnt have hypoglycemia in the last 72 hours
Detailed Description:
Primary endpoint is establishing a panel of biomarkers from 100 hypoglycemic diabetic patients with type 1 or type 2 Diabetes during the incidence of hypoglycemia by taking a single blood sample to be analyzed for HbA1c LDL HDL Triglycerides CRP CBC and biochemical analysis including liver and kidney function tests In addition to 5 ml serum sample to be centrifuged and stored in RCSI lab
Inpatient hypoglycemic patients may also be included in group of hypoglycemia and will be required to have a serial of blood samples taken to be analyzed on the 1st hour 2nd hour 3rd hour and 4th hour after the hypoglycemic event
Secondary endpoint involves recruitment of 100 control Diabetic patients with type 1 or type 2 Diabetes to establish a panel of biomarkers by obtaining a blood sample for the HbA1c LDL HDL Triglycerides CRP CBC and biochemical analysis including liver and kidney function tests to include 50 subjects fasting overnight and the other 50 subjects to be non-fasting but without having hypoglycemia at the time of recruitment or in the last 72 hours
Inpatient hypoglycemic patients may also be included in group of hypoglycemia and will be required to have a serial of blood samples taken to be analyzed on the 1st hour 2nd hour 3rd hour and 4th hour after the hypoglycemic event
Secondary endpoint involves recruitment of 100 control Diabetic patients with type 1 or type 2 Diabetes to establish a panel of biomarkers by obtaining a blood sample for the HbA1c LDL HDL Triglycerides CRP CBC and biochemical analysis including liver and kidney function tests to include 50 subjects fasting overnight and the other 50 subjects to be non-fasting but without having hypoglycemia at the time of recruitment or in the last 72 hours
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