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RecruitingPhase 2 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 weeks
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests exercise and insulin given as a nose spray in adults ages 55–80 with type 2 diabetes. It looks at whether using both may help thinking, memory, and how the brain responds to insulin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 55–80.
  • Have type 2 diabetes, or tests showing HbA1c above 6.5% and fasting blood sugar above 126 mg/dL. HbA1c measures average blood sugar.
  • Have been prescribed one of these diabetes medicines for more than 6 months: metformin, a GLP-1 drug, a TZD, a DPP-IV inhibitor, acarbose, or an SGLT-2 inhibitor.
  • Score at least 26 on the MoCA, a test of thinking and memory.
  • Have a body mass index (BMI) of 25–40. BMI compares weight with height.
  • Do not have type 1 diabetes.
  • The exercise rule is unclear: the listing gives conflicting wording about 90 minutes of exercise per week. Ask the study team to clarify.

Who can't join

  • Have dementia or a brain or nerve disease, such as Parkinson’s disease; cannot tolerate insulin; or have had a head injury or passed out in the past 5 years.
  • Have a BMI below 25 or above 40, or a weight change of more than 2 kg (about 4.4 pounds) in the past 6 months.
  • Have recently done more than 90 minutes of moderate or hard exercise, cannot safely join an exercise program, smoke, or quit smoking less than 2 years ago.
  • Have high blood fats: triglycerides listed at 400 mg/dL or cholesterol above 260 mg/dL; or uncontrolled blood pressure above 160/100.
  • Have cancer or another serious illness that the study doctor thinks could affect safety or study results, including heart, lung, liver, kidney, blood, digestive, hormone, or blood sugar problems.
  • Are pregnant or breastfeeding, or have a major mental health condition, such as psychosis, bipolar disorder, major depression, or alcohol or drug abuse.
  • Have MRI scan concerns, such as past brain surgery or head injury, unsafe metal or devices in the body, certain metal pins or plates, metal-related eye injuries, welding without a face mask, or lead or iron tattoos. Dental fillings and permanent retainers are generally allowed, but some upper retainers may affect the scans.
  • Have a strong fear of closed spaces, deafness, or a back problem that prevents lying still comfortably for up to 90 minutes.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

NJ