Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Our goal is to determine the acute effects of intranasal insulin on regional perfusion and cognition of older adults. We propose a pilot study to examine the effect of a single dose of intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled, cross-over design.

Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in older patients with T2DM as compared with placebo and compared with the control group.

Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory and executive function in diabetic patients as compared with placebo and compared with control group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Boston University; Joslin Diabetes Center; Peking University; University of Arkansas; University of Massachusetts, Worcester; University of Washington; VA Boston Healthcare System; Wake Forest School of Medicine; Wake Forest University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Diabetes group:

• 30 men and women aged >50 years old diagnosed with T2DM and treated > 5 years with oral agents

• Diabetes severity will be assessed from diabetes duration, hemoglobin A1C, and fasting glucose levels.

Control group:

• 30 healthy men and women aged >50 years selected to have the same age and sex distributions as the diabetic subjects

• Normotensive, not treated for any systemic disease, and have normal fasting blood glucose.

Exclusion Criteria:

• Type 1 Diabetes Mellitus

• History of severe hypoglycemia or hypoglycemic episode during home baseline monitoring

• Positive stress test for CAD or other ischemic conditions

• Carotid stenosis > 50% by medical history

• History of a clinically documented stroke

• Treatment with any medications administered intranasally including intranasal steroids

• Any previous adverse or allergic reactions to insulin

• Acute or unstable medical condition including Myocardial infarction or major illness and surgery within six months

• Liver or renal failure or transplant

• Uncontrolled hypertension (systolic BP >180 and/or diastolic BP >100 mm Hg or subjects taking more than 3 antihypertensive medications)

• Seizure disorders

• Malignant tumors

• Clinical dementia (by history) or inability to follow details of the protocol(MMSE (Mini Mental Status Exam) score (≥3 points below the Comparative Normal Value for the subject's age group and education level, or ≤ 24)

• Current recreational drug or alcohol abuse

• Morbid obesity (BMI >40)

• Inability to obtain permission for participation from the primary care physician

• Transcranial Doppler (TCD) exclusion criterion - poor insonation window and TCD signal

• MR exclusion criteria - any metal or bioimplants not compatible with 3 Tesla MRI and claustrophobia

• Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis