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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance

NCT03383822

Insulin Resistance

COMPLETED PHASE1/PHASE2

Effects of Age and Obesity on Brain Insulin Sensitivity

NCT04372849

Insulin Resistance Obesity

COMPLETED NA

Effect of Intranasal Insulin on Cognitive Processes and Appetite

NCT03632681

Obesity

COMPLETED NA

"Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"

NCT03929419

Insulin Sensitivity

COMPLETED NA

Influence of Central Nervous Insulin Sensitivity on Insulin Secretion

NCT02870361

Insulin Secretion

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Type 2 diabetes mellitus (T2DM) is a major risk factor for vascular dementia. DM alters insulin transport across blood-brain barrier affecting perfusion and neuronal function. Intranasal administration enables effective delivery of insulin to the brain. Clinical studies demonstrated improvement of cognitive function and memory in healthy and cognitively impaired people.

Aim 1: To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on 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. We will use transcranial Doppler to determine the effects on intranasal insulin vs. placebo on cerebral autoregulation based on measurements of beat-to-beat pressure flow velocity relationship.

Aim 2: To determine whether intranasal insulin improves cognitive functioning in older T2DM patients as compared with placebo and the control group.

This translational study will address an important area about the effects of intranasal insulin on cerebral blood flow regulation and cognition in older diabetics that has not been studied. Intranasal insulin administration may provide a novel therapeutic target for prevention and treatment of microvascular disease and cerebrovascular complications of T2DM. If successful, this approach may have significant impact on the clinical management of large population of older adults with T2DM.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insulin vs. placebo

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

Group Type EXPERIMENTAL

Intranasal insulin

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

The acute effects of intranasal sterile saline.

Healthy vs. Diabetic

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

Group Type OTHER

Intranasal insulin

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

The acute effects of intranasal sterile saline.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal insulin

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

Intervention Type DRUG

Placebo

The acute effects of intranasal sterile saline.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Novolin R

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diabetes group:

* 30 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:

* 30 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.

Exclusion Criteria

* 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)
* Inability to obtain permission for participation from the primary care physician
* Transcranial Doppler (TCD) exclusion criterion - poor insonation window and TCD signal
* Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes