Home Sleep and Circadian Phase: Mediators of Diabetes Risk

NCT01786564 | Completed Results

• 1 other identifier: STU00204605
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Deprivation; Diabetes; Circadian Dysregulation

Keywords

diabetes; sleep

Outcome Measures

Primary Outcomes (1)

• Oral Disposition Index

  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.

  baseline

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit a total of 100 African Americans (AA) and 100 non-Hispanic whites (WH) with equal numbers of men and women in each group completing the entire study. Ages will be 21-50 years and body mass indices (BMI) will be \<40 kg/m2.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Diabetes Mellitus; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Study sample was lower than anticipated.

Results Point of Contact

• Title: Kristen Knutson
• Organization: Northwestern University

kristen.knutson@northwestern.edu

312-503-1526

Study Officials

• Kristen Knuston, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: December 6, 2011
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 27, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)