Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus

In brief

To determine if restoring normal metabolic function in patients with either Type I or Type II Diabetes can improve overall cognitive function. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion and high amounts of oral glucose consumption.

Key facts

Study ID

NCT00228865

Run by

Florida Atlantic University

People needed

75

Starts

2003-06-01

Expected to finish

2009-08-01

Last updated by the study team

2016-08-10

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• diagnosed with type 1 or type 2 diabetes mellitus.
• Self reporting or diagnosed with memory changes
• Taking oral agents and/or insulin for diabetic control
• Under Endocrinologist's supervision for diabetes management
• Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• Ability to commit to the weekly time requirements associated with the study

You may not qualify if…

• Other causes of cognitive impairment not related to diabetes
• Inability to take cognitive testing
• Lack of intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Positive HIV
• Inability to breathe into machine for respiratory quotients

Where it is running

• Florida Atlantic University — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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