Status:
TERMINATED
Sleep Effectiveness and Insulin and Glucose Homeostasis
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Diabetes
Prediabetic
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the influence of sleep effectiveness on glucose and insulin metabolism in health and disease (prediabetes and type two diabetes). We will monitor sleep effecti...
Detailed Description
Evidence from experimental studies supports the hypothesis that fragmented or insufficient sleep contributes to impaired glucose and insulin homeostasis. The sleep spectrogram, an EEG-independent meas...
Eligibility Criteria
Inclusion
- Healthy volunteers, men and women 18-64 years of age.
- Fluent English speakers.
- Health status as per criteria listed for prediabetes and diabetes (based on 2003 American Diabetes Association criteria and 2009 International Expert Committee Report: Prediabetics will have impaired glucose tolerance with fasting plasma glucose (FPG) 100-125 mg/dL, Hemoglobin A1C 5.7-6.4%, or 2-hour plasma glucose (PG) 140-199 mg/dL after 75-g oral glucose tolerance test (OGTT). Diabetics will have FPG ≥ 126 mg/dL, Hemoglobin A1C ≥ 6.5%, or 2-hour PG ≥ 200 mg/dL on OGTT.
Exclusion
- Primary psychiatric disease or conditions which may independently contribute to sleep fragmentation or may hinder the subject's ability to complete the proposed testing:
- Respiratory, liver, or clotting disorders
- History of sleep disordered breathing, Restless legs syndrome or Periodic limb movement disorder or high clinical suspicion of sleep disordered breathing or other sleep disorder (e.g., snoring, excessive daytime sleepiness, frequent napping, excessive motor activity)
- Shift worker or circadian phase disorder
- Abnormal resting ECG, pacemaker, atrial fibrillation or other arrhythmia
- Seizure disorder
- History of depression, bipolar disorder, anxiety disorder, schizophrenia or use of psychiatric medication
- Narcolepsy
- Tobacco or recreational drug use
- Pregnancy or lactation
- Regular use of stimulants or hypnotic medication
- Evidence of sleep apnea (Apnea-Hypopnea Index \> 10 on screening sleep study)
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01887691
Start Date
October 1 2012
End Date
December 1 2019
Last Update
December 19 2019
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215