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Clinical trial Recruiting at 4 sites Phase2; Phase3 Interventional Ages 55 to 80

Exercise and nasal insulin in Type 2 diabetes: does adding insulin spray help the brain more

Official title: Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes

Run by Rutgers, The State University of New Jersey · NCT07675499 · Data updated 2026-11-12

In older adults with Type 2 diabetes, researchers are testing whether combining regular exercise with an intranasal insulin spray improves brain blood flow and thinking abilities more than exercise with a placebo spray.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages55 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Locations4 sites (New Brunswick, New Jersey and 3 other locations)
StatusRecruiting
StartedAugust 3, 2026
Main results expectedMay 18, 2029
Study endsMay 31, 2029
Registry record updatedJune 30, 2026
Trial IDNCT07675499 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 55–80 with Type 2 diabetes, BMI 25–40, MoCA ≥26, on standard diabetes medications, and not recently active.

Probably not a fit

Participants with dementia, certain neurologic conditions, uncontrolled hypertension, or BMI outside the 25–40 range may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 trial compares two groups of adults aged 55–80 with Type 2 diabetes. All participants will follow a supervised exercise program three times weekly for 16 weeks and receive either intranasal insulin or a placebo spray. The study uses brain imaging, cognitive testing, and blood analyses to assess brain insulin use, brain blood flow, fitness, and body composition before and after the intervention. Outcomes will help determine if combining exercise with intranasal insulin offers added brain benefits beyond exercise alone.

Why it matters

Potential benefit: If successful, the approach could improve brain health and cognitive function in older adults with Type 2 diabetes.

How similar studies have gone: Previous work suggests exercise and intranasal insulin may each benefit brain health; combining them is a novel approach with limited precedent.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Robert Wood Johnson University Hospital Clinical Research Center
    New Brunswick, New Jersey, United States     Recruiting
  • Institute for Food, Nutrition, and Health
    New Brunswick, New Jersey, United States     Recruiting
  • Rutgers University Loree Gymnasium
    New Brunswick, New Jersey, United States     Recruiting
  • Center for Advanced Human Brain Imaging Research
    Piscataway, New Jersey, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.