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NCT06424652 · ClinicalTrials.gov registry record · NA
Effect of Physiologic Insulin Administration on Cognition
A NA study, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT06424652 is a NA study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 1 participants.
The verdict
NCT06424652, a NA study, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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 Alzheimer's 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 Parkinson's Disease was treated with this pulsed insulin paradigm and experienced dramatic improvement that has now been maintained over years. Parkinson's 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 Alzheimer's 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 Alzheimer's 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 Parkinson's disease. The cognition in the Alzheimer's disease patient will be thoroughly evaluated with questionnaires and walking on a special mat while doing
Interventions
- OTHER Blood draws
- OTHER Resting Metabolic Rate (RMR)
- OTHER Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2025-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06424652
The ClinicalTrials.gov registry entry for NCT06424652 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blood draws is the first listed.
NCT06424652 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06424652 about?
NCT06424652 is a clinical study titled "Effect of Physiologic Insulin Administration on Cognition". 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 Alzheimer's Disease as type 3...
What is the current status of trial NCT06424652?
This trial is currently completed. It is a NA study. The enrollment target is 1 participants. The study started on 2024-05-16. Estimated completion is 2025-03-01.
What interventions are being tested in trial NCT06424652?
The interventions under investigation include: Blood draws (OTHER), Resting Metabolic Rate (RMR) (OTHER), Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test (OTHER).
Who is sponsoring clinical trial NCT06424652?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
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