Effect of Physiologic Insulin Administration on Cognition

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Other: Blood draws; Other: Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test; Other: Resting Metabolic Rate (RMR)

• Registration Number: NCT06424652
• Lead Sponsor: Pennington Biomedical Research Center

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 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 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 Alzheimer's disease.

Study Timeline

• Study Start: 2024-05-16
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Early Alzheimer's Disease
• Insulin Resistance

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Exclusion Criteria

• Inability to walk
• Unable to read, understand or inability to complete questionnaire
• Belong to a vulnerable group like prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Participant with Evidence of cognitive impairment.	Blood draws	-
Single Participant with Evidence of cognitive impairment.	Resting Metabolic Rate (RMR)	-
Single Participant with Evidence of cognitive impairment.	Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test	-

Primary Outcome Measures

Name	Time	Method
Effect of tissue sensitivity to insulin	Two weeks	To determine the effect of tissue sensitivity to insulin delivered in pulses compared to insulin delivered continuously during the hyperinsulinemic euglycemic clamp test (clamp). The hypothesis is that delivery of insulin in pulses during the clamp (pulsatile clamp) will increase glucose disposal rate (GDR) compared to continuous delivery during the clamp (continuous clamp). To test the hypothesis, we will measure GDR during one pulsatile clamp and one continuous clamp at 40mU/m2/min insulin infusion.

Secondary Outcome Measures

Name	Time	Method
Effect of the pulsatile clamp at 40mU/m2/min insulin infusion on signs and symptoms of Alzheimer's disease	Two weeks	To determine the effect of the pulsatile clamp at 40mU/m2/min insulin infusion on signs and symptoms of Alzheimer's disease. The hypothesis is that the signs and symptoms of Alzheimer's disease will improve following four pulsatile clamp treatments. To test the hypothesis, we will conduct assessments of cognition, homeostatic model assessment of insulin resistance, and brain insulin resistance prior to and following four pulsatile insulin clamps conducted twice weekly for two weeks.

Trial Locations

Locations (1)

Penningto Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States