Exercise and Intranasal Insulin in Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age55-80
SponsorRutgers, The State University of New Jersey
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Intranasal Insulin
- Intranasal Placebo
- High Intensity Exercise
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rutgers, The State University of New Jersey
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov