Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-02-20

Brief Summary

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To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

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Detailed Description

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Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Conditions

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Insulin Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind, placebo controlled trial

Study Groups

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Passive Control

20 minute sedentary control period during which participants watched an emotionally neutral video.

Group Type ACTIVE_COMPARATOR

60 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

80 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

100 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

120 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Placebo into the intranasal mucosa

Intervention Type DRUG

6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer

20 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

40 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Acute Exercise

20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video.

Group Type EXPERIMENTAL

60 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

80 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

100 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

120 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Placebo into the intranasal mucosa

Intervention Type DRUG

6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer

20 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

40 IU NovoLog Insulin aspart into the intranasal mucosa

Intervention Type DRUG

4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Interventions

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60 IU NovoLog Insulin aspart into the intranasal mucosa

3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

80 IU NovoLog Insulin aspart into the intranasal mucosa

2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

100 IU NovoLog Insulin aspart into the intranasal mucosa

1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

120 IU NovoLog Insulin aspart into the intranasal mucosa

6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

Placebo into the intranasal mucosa

6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

20 IU NovoLog Insulin aspart into the intranasal mucosa

5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

40 IU NovoLog Insulin aspart into the intranasal mucosa

4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Intervention Type DRUG

Other Intervention Names

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Saline NovoLog Insulin aspart NovoLog Insulin aspart NovoLog Insulin aspart NovoLog Insulin aspart NovoLog Insulin aspart NovoLog Insulin aspart

Eligibility Criteria

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Inclusion Criteria

1. Participants must be over the age of 18..
2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria

1. Lack of consent.
2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
3. Type I or Type II Diabetes
4. Self-reported pregnancy
5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes