Trial Outcomes & Findings for Mechanisms of Insulin Facilitation of Memory (NCT NCT01145482)

Results Overview

Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

15 minutes post insulin or placebo administration

Results posted on

2014-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin First, Then Saline 20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions	Saline First, Then Insulin 200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
First Intervention (1 Day) STARTED	6	6
First Intervention (1 Day) COMPLETED	6	5
First Intervention (1 Day) NOT COMPLETED	0	1
Second Intervention (1 Day) STARTED	5	6
Second Intervention (1 Day) COMPLETED	5	6
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin First, Then Saline 20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions	Saline First, Then Insulin 200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
First Intervention (1 Day) Withdrawal by Subject	0	1

Baseline Characteristics

Mechanisms of Insulin Facilitation of Memory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin First, Then Saline n=5 Participants 20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions	Saline First, Then Insulin n=6 Participants 200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions	Total n=11 Participants Total of all reporting groups
Age, Continuous	73.8 years STANDARD_DEVIATION 8.58 • n=5 Participants	74.33 years STANDARD_DEVIATION 5.92 • n=7 Participants	74.09 years STANDARD_DEVIATION 6.54 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes post insulin or placebo administration

Population: per protocol

Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.

Outcome measures

Outcome measures
Measure	Insulin n=11 Participants 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle	Saline n=11 Participants 200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
Cerebral Glutamate Concentration	1.34 ratio Standard Deviation 0.12	1.34 ratio Standard Deviation 0.17

SECONDARY outcome

Timeframe: 15 minutes post insulin or placebo administration

Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance

Outcome measures

Outcome measures
Measure	Insulin n=11 Participants 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle	Saline n=11 Participants 200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
Memory	6.73 units on a scale Standard Deviation 6.25	5.36 units on a scale Standard Deviation 2.69

Adverse Events

Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin n=11 participants at risk 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle	Saline n=11 participants at risk 200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
Gastrointestinal disorders nausea and urge to vomit	0.00% 0/11 • immediately following study visits	9.1% 1/11 • Number of events 1 • immediately following study visits

Additional Information

Dr. Andreana Haley

The University of Texas at Austin

Phone: 512-232-0863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place