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OpenTrials
Completed

NCT Number: NCT00721019

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

5-hour bedtime

Other

10 days with sleep restricted only to a 5-hour bedtime period at night

8.5-hour bedtimes

Other

10 days with sleep allowed only during a 8.5-hour period at night

Primary outcomes

  1. Total body insulin sensitivity

    Time frame: at the end of each bedtime intervention

Secondary outcomes

  1. First and second phase insulin secretion

    Time frame: at the end of each bedtime intervention

  2. Endogenous glucose production

    Time frame: at the end of each bedtime intervention

  3. Glycerol turnover and free fatty acid concentrations

    Time frame: at the end of each bedtime intervention

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Sleep, Energy Metabolism and Diabetes Risk.

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 23, 2008
Registry last updated
Sep 5, 2013

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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