Type 2 Diabetes (T2D) Clinical Trials

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Effects of Intranasal Insulin Plus Exercise Training on Brain Blood Flow, Neuronal Insulin Signaling, and Cognition in Adults With Type 2 Diabetes

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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. 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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Institute for Food, Nutrition, and Health
RECRUITING
New Brunswick
Robert Wood Johnson University Hospital Clinical Research Center
RECRUITING
New Brunswick
Rutgers University Loree Gymnasium
RECRUITING
New Brunswick
Center for Advanced Human Brain Imaging Research
RECRUITING
Piscataway
Contact Information
Primary
Steven K Malin, PhD
steven.malin@rutgers.edu
848-932-7540
Backup
Emily M Heiston, PhD
emily.heiston@rutgers.edu
848-932-7540
Time Frame
Start Date: 2026-08-03
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 60
Treatments
Placebo_comparator: HiEx with Intranasal Placebo
Active_comparator: HiEx with Intranasal Insulin
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov