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Completed

NCT Number: NCT01786564

Home Sleep and Circadian Phase: Mediators of Diabetes Risk

The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.

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Key information

Conditions

Sleep Deprivation Chronobiology Disorders Circadian Dysregulation Diabetes Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 21-50 years
  • BMI <40 kg/m2.
  • No major illness.
  • No history of psychiatric, endocrine, cardiac or sleep disorders,
  • Premenopausal, non-pregnant women.
  • Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).

Exclusion criteria

include:

  • Persons with diabetes.
  • Persons with diagnosed sleep disorders or apnea-hypopnea index>15.
  • History of cardiovascular event or disease (excluding controlled hypertension).
  • Major psychiatric disorder or other major illness.
  • Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).
  • Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.
  • Anyone who tests positive for common drugs of abuse.
  • People with color blindness.
  • People who have had Lasik eye surgery.
  • People who work night shifts.
  • Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.

Treatment and study plan

Primary outcomes

  1. Oral Disposition Index

    Time frame: baseline

    The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2013
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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