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NCT02687893 · ClinicalTrials.gov registry record · NA

Effect of Hypoglycemia on Sleep

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT02687893: Completed NA study, sponsored by Oregon Health and Science University.

NCT02687893 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02687893, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies. Although severe hypoglycemia is associated with adverse events such as seizures and death, less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle. The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.

Primary Outcome

The mean duration of time in hypoglycemia in minutes (defined as sensor glucose less than 70 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4 for 16 hours after the beginning of exercise.

Interventions

  • BEHAVIORAL Aerobic Exercise
  • BEHAVIORAL Resistance Exercise

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-02
Est. Completion 2018-07-18
Phase NA

What the finished NCT02687893 record still lists

NCT02687893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

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

NCT02687893 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02687893 about?

NCT02687893 is a clinical study titled "Effect of Hypoglycemia on Sleep". Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sl...

What is the current status of trial NCT02687893?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2016-02. Estimated completion is 2018-07-18.

What interventions are being tested in trial NCT02687893?

The interventions under investigation include: Aerobic Exercise (BEHAVIORAL), Resistance Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT02687893?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02687893's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02687893, the US trial registry maintained by the National Library of Medicine. NCT02687893 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.