Status:
COMPLETED
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Boston University
Joslin Diabetes Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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 insu...
Detailed Description
Type 2 diabetes mellitus (T2DM) is a major risk factor for vascular dementia. DM alters insulin transport across blood-brain barrier affecting perfusion and neuronal function. Intranasal administratio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01206322
Start Date
May 1 2010
End Date
April 1 2013
Last Update
June 26 2019
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215