Type 2 DiabetesPhase 2/3NCT07675499
Exercise and Intranasal Insulin in Type 2 Diabetes
A Phase 2/3 study testing Intranasal Insulin and High Intensity Exercise in people with Type 2 Diabetes and Insulin Sensitivity/Resistance, run by Rutgers, The State University of New Jersey at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Insulin Sensitivity/Resistance, Cognition
- What is being tested?
- Intranasal Insulin and High Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Aug 2026to 31 May 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, 08091
Fei Chen, 732-235-5966, chenf2@rwjms.rutgers.edu
- Recruiting
Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, 08901
Sue Shapses, PhD, shapses@rutgers.edu
- Recruiting
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, 08901
Steven Malin, PhD, 848-932-7540, steven.malin@rutgers.edu
- Recruiting
Center for Advanced Human Brain Imaging Research
Piscataway, New Jersey, 08854
David Zald, PhD, 732-235-7211, dz268@rbhs.rutgers.edu
About this study
Official title: Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes
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.
Read the detailed description
This goal of this study is to find out if exercise plus an insulin nose spray works better than exercise alone for brain blood flow in older adults with Type 2 Diabetes. This study will also look at how the brain uses insulin and thinking skills. Individuals will be randomized to one of two groups. One group will exercise and use an insulin nose spray. The other group will exercise and use a saline (placebo) nose spray. Exercise training will be supervised and consist of walking or light jogging 3 times per week for 16 weeks. Brain imaging, cognition, and blood tests will be conducted before and after the intervention. Other measures include fitness tests and body composition scans.
- Being tested
- Intranasal Insulin, Intranasal Placebo, High Intensity Exercise
- Keywords
- Exericse, Intranasal Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
Dosage will be 20 IU of INI twice per day (40 IU in total/day). The study will use the Kurve Technology intranasal device, which delivers a 20 second stream of insulin through a nose piece into a nostril, after which the device switches off. The process will then be repeated in the other nostril.
Intranasal PlaceboDrug
Saline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device.
High Intensity ExerciseBehavioural
High intensity exercise will consist of 16 weeks of walking at ~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk. The duration of each exercise session will be adjusted based on fitness level so that ~300 kcal will be expended per training session during weeks 1-2, 350 kcal per training session during weeks 3-4, and 400 kcal per training session during weeks 5-16. This usually equals ~60 minutes per session but can vary from person to person. Each session will start with a 5-minute warm-up and end with a 5-minute cool down. During each exercise session, individuals will wear a heart rate monitor rating of perceived exertion will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| HiEx with Intranasal Placebo | Placebo comparator | Not described Receives: Drug: Intranasal Placebo; Behavioral: High Intensity Exercise |
| HiEx with Intranasal Insulin | Active comparator | Not described Receives: Drug: Intranasal Insulin; Behavioral: High Intensity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Insulin Sensitivity
People will undergo a motion corrected diffusion weighted gradient-and spin echo pseudo-Continuous Arterial Spin Labeling (pCASL) sequence with 5 post labelling delays. This provides 3.5 mm3 resolution for whole brain coverage for CBF. CBF will be determined via the hippocampus.
Participants will then be administrated INI at a dose of 40 IU of human insulin (0.4 ml, Humulin, Eli Lilly \& Co., Indianapolis, IN). Single puffs of 0.1ml will occur 4 times (twice each nostril) over 2 minutes via the VianaseTM electronic atomizers (Kurve Technology Inc., Lynnwood, WA). After 30 minutes, scanning will be repeated to determine CBF changes to indicate brain insulin sensitivity. Brain insulin sensitivity will be defined as the change from fasting to INI (e.g. CBFINI - CBFfast).
Measured: Change from baseline to the end of the intervention at 16 weeks
Secondary outcomes (7)
Blood Brain Barrier Integrity
People will undergo a motion corrected diffusion weighted gradient-and spin echo pseudo-Continuous Arterial Spin Labeling (pCASL) sequence with 5 post labelling delays. This provides 3.5 mm3 resolution for whole brain coverage for BBB water exchange (Kw). Kw will serve as primary index of BBB integrity.
Participants will then be administrated INI at a dose of 40 IU of human insulin (0.4 ml, Humulin, Eli Lilly \& Co., Indianapolis, IN). Single puffs of 0.1ml will occur 4 times (twice each nostril) over 2 minutes via the VianaseTM electronic atomizers (Kurve Technology Inc., Lynnwood, WA). After 30 minutes, scanning will be repeated to determine BBB changes from fasting to INI (e.g. KwINI - Kwfast).
Measured: Change from baseline to the end of the intervention at 16 weeks
Insulin Signaling Proteins
Insulin signaling proteins pIRS-1Ser636 and pAktSer473, derived from neuronal extracellular vesicles (nEVs) will be measured before and 30 minutes after intranasal insulin (e.g. nEVsINI - nEVsfast).
nEVs will be isolated from plasma samples through a 2-step method: 1) isolating total plasma nEVs via Size Exclusion Chromatography (SEC) and selective immunocapture targeting three neuronal-specific epitopes on intact EVs (L1CAM, NLGN3, and GAP43). Isolated nEVs concentration and size distribution will be assessed by nanoparticle tracking analysis (NTA). nEV concentration will be used to normalize protein biomarker values to account for differential recovery.
Measured: Change from baseline to the end of the intervention at 16 weeks
Augmentation Index
Brachial artery augmentation index (AIx75) will be tested in the semi-supine position using the SphygmoCor device to depict arterial stiffness before and after INI (e.g. AIx75INI - AIx75fast).
Measured: Change from baseline to the end of the intervention at 16 weeks
Peripheral Insulin Sensitivity
A 120 minute 75g OGTT will be used to depict insulin sensitivity.
Measured: Change from baseline to the end of the intervention at 16 weeks
Cognitive Function
Cognitive function will be assessed via the NIH toolbox. The NIH toolbox is an iPad application that consists of cognitive, emotional, motor, and sensory function assessments. Specific measurements will include: Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Pattern Comparison Processing Speed Test, and Picture Sequence Memory Test.
Measured: Change from baseline to the end of the intervention at 16 weeks
Pulse Wave Velocity
Pulse Wave Velocity (PWV) will be tested in the semi-supine position using the SphygmoCor device to depict arterial stiffness before and after INI (i.e. PWV-INI - PWV-fast).
Measured: Change from baseline to the end of the intervention at 16 weeks
Insulin Secretion
A 120 minute 75g OGTT will be used to depict insulin secretion. Using the oral c-peptide minimal model (OMM), an estimate of 3 insulin secretion patterns will be be obtained: 1) one that is proportional to glucose rate change (i.e. early phase); 2) another proportional to plasma glucose above a threshold after a delay (i.e. late phase); and 3) total responsivity index, (total phase).
Measured: Change from baseline to the end of the intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start3 Aug 2026 (estimated)
- Primary completion18 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive high intensity exercise training with intranasal insulin or high intensity exercise training with intranasal placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K Malin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Steven K Malin, PhD, Principal investigator, Rutgers University - New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675499
- Sponsor's protocol ID
- Pro2026000751
- Other IDs
- 1R01DK147509-01
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malin SK, Battillo DJ, Beeri MS, Mustapic M, Kapogiannis D. A Single Bout of Aerobic Exercise Increases Neuronal Extracellular Vesicle-Derived Insulin Signaling Biomarkers in Adults With Cardiometabolic Risk. Compr Physiol. 2026 Apr;16(2):e70131. doi: 10.1002/cph4.70131.
PubMed 41876945Malin SK, Battillo DJ, Zald DH, Ramirez J. Appetite Perception and Cerebral Blood Flow in Aging Adults Following a Single Bout of Exercise. Nutrients. 2026 Mar 27;18(7):1072. doi: 10.3390/nu18071072.
PubMed 41978122Malin SK, Zald DH, Battillo DJ. Acute exercise reduces intranasal insulin-mediated elevations in blood pressure in aging adults with cardiometabolic risk. Am J Physiol Regul Integr Comp Physiol. 2026 Aug 1;331(2):R147-R154. doi: 10.1152/ajpregu.00119.2026. Epub 2026 Jun 15.
PubMed 42295834Malin SK, Battillo DJ, Beeri MS, Mustapic M, Delgado-Peraza F, Kapogiannis D. Two weeks of exercise alters neuronal extracellular vesicle insulin signaling proteins and pro-BDNF in older adults with prediabetes. Aging Cell. 2025 Jan;24(1):e14369. doi: 10.1111/acel.14369. Epub 2024 Oct 18.
PubMed 39421964
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07675499
- Acronym / sponsor ID
- Pro2026000751
- Keywords
- Exericse, Intranasal Insulin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 18 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This goal of this study is to find out if exercise plus an insulin nose spray works better than exercise alone for brain blood flow in older adults with Type 2 Diabetes. This study will also look at how the brain uses insulin and thinking skills. Individuals will be randomized to one of two groups. One group will exercise and use an insulin nose spray. The other group will exercise and use a saline (placebo) nose spray. Exercise training will be supervised and consist of walking or light jogging 3 times per week for 16 weeks. Brain imaging, cognition, and blood tests will be conducted before and after the intervention. Other measures include fitness tests and body composition scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive high intensity exercise training with intranasal insulin or high intensity exercise training with intranasal placebo.
| Arm | Type | Receives |
|---|---|---|
| HiEx with Intranasal Placebo | Placebo comparator | Drug: Intranasal Placebo, Behavioral: High Intensity Exercise |
| HiEx with Intranasal Insulin | Active comparator | Drug: Intranasal Insulin, Behavioral: High Intensity Exercise |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal InsulinDosage will be 20 IU of INI twice per day (40 IU in total/day). The study will use the Kurve Technology intranasal device, which delivers a 20 second stream of insulin through a nose piece into a nostril, after which the device switches off. The process will then be repeated in the other nostril. | Drug | HiEx with Intranasal Insulin |
| Intranasal PlaceboSaline will be administered twice daily (20 seconds in each nostril) using the Kurve Technology intranasal insulin device. | Drug | HiEx with Intranasal Placebo |
| High Intensity ExerciseHigh intensity exercise will consist of 16 weeks of walking at ~85% of each participant's predetermined VO2max and monitored via heart rate. Supervised exercised will occur on a treadmill 3d/wk. The duration of each exercise session will be adjusted based on fitness level so that ~300 kcal will be expended per training session during weeks 1-2, 350 kcal per training session during weeks 3-4, and 400 kcal per training session during weeks 5-16. This usually equals ~60 minutes per session but can vary from person to person. Each session will start with a 5-minute warm-up and end with a 5-minute cool down. During each exercise session, individuals will wear a heart rate monitor rating of perceived exertion will be recorded. | Behavioural | HiEx with Intranasal Insulin, HiEx with Intranasal Placebo |
Primary outcome
Cerebrovascular Insulin Sensitivity
Time frame: Change from baseline to the end of the intervention at 16 weeks
People will undergo a motion corrected diffusion weighted gradient-and spin echo pseudo-Continuous Arterial Spin Labeling (pCASL) sequence with 5 post labelling delays. This provides 3.5 mm3 resolution for whole brain coverage for CBF. CBF will be determined via the hippocampus. Participants will then be administrated INI at a dose of 40 IU of human insulin (0.4 ml, Humulin, Eli Lilly \& Co., Indianapolis, IN). Single puffs of 0.1ml will occur 4 times (twice each nostril) over 2 minutes via the VianaseTM electronic atomizers (Kurve Technology Inc., Lynnwood, WA). After 30 minutes, scanning will be repeated to determine CBF changes to indicate brain insulin sensitivity. Brain insulin sensitivity will be defined as the change from fasting to INI (e.g. CBFINI - CBFfast).
7 secondary outcomes
Blood Brain Barrier Integrity
Time frame: Change from baseline to the end of the intervention at 16 weeks
Insulin Signaling Proteins
Time frame: Change from baseline to the end of the intervention at 16 weeks
Augmentation Index
Time frame: Change from baseline to the end of the intervention at 16 weeks
Peripheral Insulin Sensitivity
Time frame: Change from baseline to the end of the intervention at 16 weeks
Cognitive Function
Time frame: Change from baseline to the end of the intervention at 16 weeks
Pulse Wave Velocity
Time frame: Change from baseline to the end of the intervention at 16 weeks
Insulin Secretion
Time frame: Change from baseline to the end of the intervention at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 41876945Malin SK, Battillo DJ, Beeri MS, Mustapic M, Kapogiannis D. A Single Bout of Aerobic Exercise Increases Neuronal Extracellular Vesicle-Derived Insulin Signaling Biomarkers in Adults With Cardiometabolic Risk. Compr Physiol. 2026 Apr;16(2):e70131. doi: 10.1002/cph4.70131.
- Background: PubMed 41978122Malin SK, Battillo DJ, Zald DH, Ramirez J. Appetite Perception and Cerebral Blood Flow in Aging Adults Following a Single Bout of Exercise. Nutrients. 2026 Mar 27;18(7):1072. doi: 10.3390/nu18071072.
- Background: PubMed 42295834Malin SK, Zald DH, Battillo DJ. Acute exercise reduces intranasal insulin-mediated elevations in blood pressure in aging adults with cardiometabolic risk. Am J Physiol Regul Integr Comp Physiol. 2026 Aug 1;331(2):R147-R154. doi: 10.1152/ajpregu.00119.2026. Epub 2026 Jun 15.
- Background: PubMed 39421964Malin SK, Battillo DJ, Beeri MS, Mustapic M, Delgado-Peraza F, Kapogiannis D. Two weeks of exercise alters neuronal extracellular vesicle insulin signaling proteins and pro-BDNF in older adults with prediabetes. Aging Cell. 2025 Jan;24(1):e14369. doi: 10.1111/acel.14369. Epub 2024 Oct 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven K Malin, PhD principal investigator
Rutgers University - New Brunswick
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intranasal Insulin and High Intensity Exercise in people with Type 2 Diabetes and Insulin Sensitivity/Resistance, run by Rutgers, The State University of New Jersey at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven K Malin, PhD (848-932-7540, steven.malin@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Insulin Sensitivity (time frame: Change from baseline to the end of the intervention at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675499, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.