Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline

Completed

Started May 2010

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed

1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

October 28, 2014

Completed

Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

August 20, 2010

Results QC Date

July 24, 2014

Last Update Submit

June 17, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, blood flow, brain perfusion, cognitive function

Outcome Measures

Primary Outcomes (2)

Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)
To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg). Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order. Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo.
Acute changes within 2 hours
Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)
To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).
Acute changes within 2 hours

Study Arms (2)

Insulin vs. placebo

EXPERIMENTAL

Comparisons of acute effects of intranasal insulin or placebo (saline) on cerebral blood flow and cognition in healthy controls and type 2 diabetes.

Drug: Intranasal insulinDrug: Placebo

Healthy vs. Diabetic

OTHER

Comparisons of acute effects of intranasal insulin or placebo (saline) on cerebral blood flow and cognition in healthy controls and type 2 diabetes.

Drug: Intranasal insulinDrug: Placebo

Interventions

Intranasal insulinDRUG

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

Also known as: Novolin R

Healthy vs. DiabeticInsulin vs. placebo

PlaceboDRUG

The acute effects of intranasal sterile saline.

Healthy vs. DiabeticInsulin vs. placebo

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diabetes group:
men and women aged \>50 years old diagnosed with T2DM and treated \> 5 years with oral agents
Diabetes severity will be assessed from diabetes duration, hemoglobin A1C, and fasting glucose levels.
Control group:
healthy men and women aged \>50 years selected to have the same age and sex distributions as the diabetic subjects
Normotensive, not treated for any systemic disease, and have normal fasting blood glucose.

You may not qualify if:

Type 1 Diabetes Mellitus
History of severe hypoglycemia or hypoglycemic episode during home baseline monitoring
Positive stress test for CAD or other ischemic conditions
Carotid stenosis \> 50% by medical history
History of a clinically documented stroke
Treatment with any medications administered intranasally including intranasal steroids
Any previous adverse or allergic reactions to insulin
Acute or unstable medical condition including Myocardial infarction or major illness and surgery within six months
Liver or renal failure or transplant
Uncontrolled hypertension (systolic BP \>180 and/or diastolic BP \>100 mm Hg or subjects taking more than 3 antihypertensive medications)
Seizure disorders
Malignant tumors
Clinical dementia (by history) or inability to follow details of the protocol(MMSE (Mini Mental Status Exam) score (≥3 points below the Comparative Normal Value for the subject's age group and education level, or ≤ 24)
Current recreational drug or alcohol abuse
Morbid obesity (BMI \>40)
+2 more criteria

Contact the study team to confirm eligibility.

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

Novak V, Milberg W, Hao Y, Munshi M, Novak P, Galica A, Manor B, Roberson P, Craft S, Abduljalil A. Enhancement of vasoreactivity and cognition by intranasal insulin in type 2 diabetes. Diabetes Care. 2014;37(3):751-9. doi: 10.2337/dc13-1672. Epub 2013 Oct 7.
PMID: 24101698RESULT
Zhang H, Hao Y, Manor B, Novak P, Milberg W, Zhang J, Fang J, Novak V. Intranasal insulin enhanced resting-state functional connectivity of hippocampal regions in type 2 diabetes. Diabetes. 2015 Mar;64(3):1025-34. doi: 10.2337/db14-1000. Epub 2014 Sep 23.
PMID: 25249577RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Dr. Vera Novak
Organization: Beth Israel Deaconess Medical Center

Study Officials

Vera Novak, MD PhD
Beth Israel Deaconess Medical Center, Harvard Medical School
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD PhD, Associate Professor of Medicine

Study Record Dates

First Submitted

August 20, 2010

First Posted

September 21, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 26, 2019

Results First Posted

October 28, 2014

Record last verified: 2019-06

Locations

US(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Insulin vs. placebo

Healthy vs. Diabetic

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Insulin vs. placebo

Healthy vs. Diabetic

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations