Sleep Loss and Glucose Metabolism in People With Family History of Type 2 Diabetes.

Type 2 Diabetes Clinical Trial

Official title:

Sleep, Energy Metabolism and Diabetes Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721019
• Other study ID #: 16079A-S3
• Secondary ID: R01HL089637
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: September 4, 2013
• Start date: July 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that the carbohydrate metabolism of people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 10 days in comparison to when they have slept longer hours for 10 days.

Description:

Study participants will complete two 10-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center scheduled at least 4 weeks apart. Bedtime duration will be set at 5 hours per night during one of these stays and 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" while in the sleep laboratory. During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus. During the last two days of each inpatient stay in the laboratory, participants will undergo two different tests. The first test will determine how much insulin does their body produce in response to an intravenous glucose infusion lasting several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• regular sleep habits

• BMI 20 to 27 kg/m2

• at least one parent, sibling or grandparent with type 2 diabetes

• no regular exercise habits

Exclusion Criteria:

• active smoker

• night or shift work

• have highly variable sleep habits

• have a hormonal disorder

• have a sleep disorder

• have an active medical problem

• women only: use of birth control pills

• women only: irregular menstrual periods or pregnancy

• use of medications/compounds that can disrupt sleep

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Sleep
• Sleep Deprivation
• Type 2 Diabetes

Intervention

Other:
• 5-hour bedtime
10 days with sleep restricted only to a 5-hour bedtime period at night
• 8.5-hour bedtimes
10 days with sleep allowed only during a 8.5-hour period at night

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body insulin sensitivity		at the end of each bedtime intervention	No
Secondary	First and second phase insulin secretion		at the end of each bedtime intervention	No
Secondary	Endogenous glucose production		at the end of each bedtime intervention	No
Secondary	Glycerol turnover and free fatty acid concentrations		at the end of each bedtime intervention	No