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Could a nose spray and walking protect the aging brain?

NCT ID NCT07675499

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study investigates whether combining intranasal insulin (delivered as a nose spray) with high-intensity exercise can improve brain blood flow, insulin sensitivity, and thinking skills in older adults with type 2 diabetes. Participants aged 55–80 will receive either insulin or a placebo spray twice daily plus a 16-week exercise program. The goal is to see if this dual approach helps protect the brain from age-related decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intranasal insulin
What this could lead to
If it works, this combination could point toward a non-drug way to protect brain health and thinking skills in people with type 2 diabetes.
What could go wrong
This is a mid-stage trial with only 60 participants, so results may not apply to everyone. The approach is experimental and may not show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female 55-80 years old * Type 2 diabetes diagnosis or confirmation HbA1c \>6.5% and fasting glucose \>126 mg/dl * Individuals prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors \>6 months. * MOCA ≥26 * Body mass index (BMI) ≥25 and ≤40 kg/m2 * Not diagnosed with Type 1 diabetes * Not currently engaged in \<90 min/wk of exercise Exclusion Criteria: * A diagnosis of dementia * Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.) * Intolerance to insulin * Morbidly obese patients (BMI \>40 kg/m2) and lean patients (BMI \<25 kg/m2) * \>2 kg weight change in past 6 months * Participants who have been recently active (\>90 min of moderate/high intensity exercise) * Individuals who are smokers or who have quit smoking (\<2 years) * Hypertriglyceridemia (400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects * Uncontrolled Hypertensive (\>160/100 mmHg) * Participants with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety * Pregnant (as evidenced by positive pregnancy test) or nursing women * Participants with contraindications to participation in an exercise training program * Major psychiatric disorders (e.g. psychosis, bipolar disorder, major depression, alcohol/substance abuse) * History of head trauma or loss of consciousness in last 5 years. * Known contraindications for MR imaging: * History of head trauma or neurosurgery, or neurological disorder (other than headaches or peripheral nerve disease) as these may impact neuroimaging results. * Ferrous material implanted in or on the body, including flakes or filings, surgical clips, bullets, or electrical devices such as a pacemaker, or nonremovable ferrous jewelry (fillings in teeth and permanent retainers are permitted). * Fillings and permanent retainers do not provide a safety risk and are not general exclusions. However, upper retainers may cause artifacts in ventral frontal regions and therefore may be an exclusion for some studies. * Individuals with surgical pins or plates above the neck are excluded. Surgical pins or plates below the neck are exclusions, except when the material is fixed to bone, and considered acceptable by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, 2020 Edition. Almost all recent orthopedic implants are made of materials that are not ferromagnetic and therefore are safe for scanning, and even though some screws are still made of ferromagnetic materials these are firmly screwed into bone. In cases where the material is unknown or deemed unsafe for scanning by the Reference Manual for Magnetic Resonance Safety. Implants and Devices the participant will be excluded. * History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask * Lead/iron tattoos * Claustrophobia (history of significant anxiety in closed places). * Back problem that would prevent the subject from laying still comfortably for up to 90 minutes. * Deafness

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Advanced Human Brain Imaging Research

    RECRUITING

    Piscataway, New Jersey, 08854, United States

  • Institute for Food, Nutrition, and Health

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Robert Wood Johnson University Hospital Clinical Research Center

    RECRUITING

    New Brunswick, New Jersey, 08091, United States

  • Rutgers University Loree Gymnasium

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

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