Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes

Summary

Our goal is to determine the acute effects of intranasal insulin on regional perfusion and cognition of older adults. We propose a pilot study to examine the effect of a single dose of intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with T2DM and 30 healthy controls \>50 years old using a double blinded, placebo-controlled, cross-over design.

Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in older patients with T2DM as compared with placebo and compared with the control group.

Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory and executive function in diabetic patients as compared with placebo and compared with control group.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Intranasal insulin

The acute effects of a single 40-IU dose of intranasal insulin

DRUG

Placebo

The acute effects of intranasal sterile saline.

Sponsors & Collaborators

• Boston University

  collaborator OTHER

• Joslin Diabetes Center

  collaborator OTHER

• Peking University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• VA Boston Healthcare System

  collaborator FED

• University of Massachusetts, Worcester

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Vera Novak, MD PhD · Beth Israel Deaconess Medical Center, Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• United States

Study Locations