Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 80
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Other
Who this trial is looking for
This trial is looking for adults aged 55 to 80 with type 2 diabetes. Participants will engage in regular exercise and use a nose spray that contains insulin to see how it affects thinking and memory.
Are You a Good Fit for This Trial?
Must be takingMetforminGLP-1 agonistsTZDsDPP-IV inhibitorsAcarboseSGLT-2 inhibitors
Rules you outDementiaParkinson's diseaseHypertriglyceridemiaHypercholesterolemiaPregnancyMajor psychiatric disorders
You may be able to join if
I am between 55 and 80 years old.
I have been diagnosed with type 2 diabetes.
I have been taking diabetes medication for more than 6 months.
I have a MOCA score of 26 or higher.
My body mass index (BMI) is between 25 and 40.
I do not have type 1 diabetes.
I currently exercise less than 90 minutes a week.
You may not be able to join if
I have a diagnosis of dementia.
I have a neurological disease.
I cannot tolerate insulin.
I have had a significant weight change in the last 6 months.
I have smoked or quit smoking in the last 2 years.
I have uncontrolled high blood pressure.
I have a history of significant medical issues that could affect my safety.
I have had significant anxiety in closed spaces.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 e…
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.
Trial Locations
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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…
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
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