Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01206322
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 30
- Starts
- 2010-05-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2019-06-26
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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