Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Diabetes Clinical Trial

Official title:

Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786564
• Other study ID #: STU00204605
• Status: Completed
• Start date: December 6, 2011
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Ages 21-50 years

2. BMI <40 kg/m2.

3. No major illness.

4. No history of psychiatric, endocrine, cardiac or sleep disorders,

5. Premenopausal, non-pregnant women.

6. 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:

1. Persons with diabetes.

2. Persons with diagnosed sleep disorders or apnea-hypopnea index>15.

3. History of cardiovascular event or disease (excluding controlled hypertension).

4. Major psychiatric disorder or other major illness.

5. Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).

6. Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.

7. Anyone who tests positive for common drugs of abuse.

8. People with color blindness.

9. People who have had Lasik eye surgery.

10. People who work night shifts.

11. 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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Diabetes
• Diabetes Mellitus
• Sleep Deprivation

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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