Phase 2
N=30
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01206322 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score) — 39.46; 41.23; 43.1; 50.9 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intranasal insulin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score) |
39.46; 41.23; 43.1; 50.9 | — |
| PRIMARY Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg) |
39.2; 46.4; 40.3; 36.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01206322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.