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
- Diseases
- Type 2 diabetes
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers University Loree Gymnasium Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Institute for Food, Nutrition, and Health Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Robert Wood Johnson University Hospital Clinical Research Center Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Center for Advanced Human Brain Imaging Research Coordinator of this site? Confirm its status | Piscataway | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.