Exercise and Intranasal Insulin in Type 2 Diabetes

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes, Insulin Sensitivity/Resistance, Cognition, Brain Blood Flow

In brief

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.

Key facts

Study ID: NCT07675499
Run by: Rutgers, The State University of New Jersey
People needed: 60
Starts: 2026-08-03
Expected to finish: 2029-05-31
Last updated by the study team: 2026-06-30

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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