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NCT07675499RecruitingPhase 2/3

Exercise and Intranasal Insulin in Type 2 Diabetes

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

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

About 6.5 million adults in the United States who are 65 or older have dementia. While the exact cause of dementia is not known, it may be due to changes in the brain. Further, risk may be higher when the brain does not respond to insulin. Indeed, brain insulin resistance has emerged as a pathologic factor affecting memory, executive function as well as systemic glucose control. Regular aerobic exercise may help reduce the risk of dementia by increased blood flow to the brain and help the brain respond better to insulin. In addition, giving insulin through a nose spray (called intranasal insulin) may also help with thinking and memory. However, it is unknown if using both exercise and intranasal insulin is best for the brain.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Jun 2026
Start date
3 Aug 2026
Primary completion date
18 May 2029
Lead sponsor
Rutgers, The State University of New Jersey
NCT number
NCT07675499

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 60
  • From 3 Aug 2026 to the primary completion date, 18 May 2029
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • A diagnosis of dementia
  • Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.)
  • 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
  • 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

Lab values

  • Hypertriglyceridemia (400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects

Age

  • Individuals who are smokers or who have quit smoking (\<2 years)

Other

  • 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)
  • Uncontrolled Hypertensive (\>160/100 mmHg)
  • Pregnant (as evidenced by positive pregnancy test) or nursing women
  • Participants with contraindications to participation in an exercise training program

Who the study is looking for

  • 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

Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rutgers University Loree Gymnasium
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Institute for Food, Nutrition, and Health
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Robert Wood Johnson University Hospital Clinical Research Center
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Center for Advanced Human Brain Imaging Research
Coordinator of this site? Confirm its status
PiscatawayUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.