Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424652
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Effect of Physiologic Insulin Administration on Cognition
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Effect of Physiologic Insulin Administration on Cognition
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
In humans insulin is secreted in pulses from the pancreatic beta-cells and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range These pulses become disrupted in the presence of insulin resistance Some people have referred to Alzheimers Disease as type 3 diabetes because the glucose uptake in the brain is reduced by 30 Clinical observations in clinics that treat patients with insulin pulses every 5 minutes for 3 hours twice a week for 2 weeks followed by once a week for 6 weeks and followed by less frequency treatments suggest an improvement in type 2 diabetes control reduction in insulin resistance and an improvement in diabetes complications A patient with Parkinsons Disease was treated with this pulsed insulin paradigm and experienced dramatic improvement that has now been maintained over years Parkinsons Disease has been reported to have a decreased glucose uptake in the brain so pulsed insulin treatment was tried in a small number of patients with Alzheimers Disease and there was an impression that they showed improvement Clinics that use pulsed insulin treatment change more than one parameter of the insulin pulses which makes it difficult to determine what is giving the improvement The euglycemic hyper-insulinemic clamp also called a clamp is a well-standardized test that measures insulin resistance and involves intravenous insulin infusion This single patient study will enroll one patient with early Alzheimers disease and insulin resistance The subject will have one standard clamp test with continuous insulin followed by 4 clamps over a 2-week period using the same amount of insulin over the same period of time but administered in pulses every 5 minutes This was the number of pulsed insulin treatments needed to see a dramatic improvement in Parkinsons disease The cognition in the Alzheimers disease patient will be thoroughly evaluated with questionnaires and walking on a special mat while doing arithmetic tasks before and after the 4 pulsed insulin clamps If this study demonstrates an improvement in cognition one will know that the only thing that changed from the standard clamp was the pulse nature of the insulin delivery
Detailed Description:
The purpose of this research study is to test the effect of an insulin treatment on Alzheimers disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None