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NCT01206322 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT01206322: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.

NCT01206322 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01206322, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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.

Primary Outcome

To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score). Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg). Each participant received a single dose of intranasal insulin (INI) or placebo

Interventions

  • DRUG Placebo
  • DRUG Intranasal insulin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-05
Est. Completion 2013-04
Phase Phase 2

What the finished NCT01206322 record still lists

NCT01206322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01206322 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01206322 about?

NCT01206322 is a clinical study titled "Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes". 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 contr...

What is the current status of trial NCT01206322?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-05. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01206322?

The interventions under investigation include: Placebo (DRUG), Intranasal insulin (DRUG).

Who is sponsoring clinical trial NCT01206322?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01206322's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01206322, the US trial registry maintained by the National Library of Medicine. NCT01206322 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.