NCT07675499 Exercise and Intranasal Insulin in Type 2 Diabetes
| NCT ID | NCT07675499 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-03 |
| Primary Completion | 2029-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-08-03 with a primary completion date of 2029-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Steven K Malin, PhD
PRINCIPAL INVESTIGATOR
Rutgers University - New Brunswick
Frequently Asked Questions
Who can join the NCT07675499 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07675499 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07675499 currently recruiting?
Yes, NCT07675499 is actively recruiting participants. Contact the research team at steven.malin@rutgers.edu for enrollment information.
Where is the NCT07675499 trial being conducted?
This trial is being conducted at New Brunswick, United States, New Brunswick, United States, New Brunswick, United States, Piscataway, United States.
Who is sponsoring the NCT07675499 clinical trial?
NCT07675499 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Steven K Malin, PhD at Rutgers University - New Brunswick. The trial plans to enroll 60 participants.
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