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Completed

NCT Number: NCT00724087

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

The use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.

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Key information

Conditions

Sleep Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders Type 2 Diabetes

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart. Bedtime duration will be set at 5.5 hours per night during one of these stays and at 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" 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. At the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. Several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time. At the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and 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
  • must exercise regularly

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

5.5-hour bedtime

Other

16 days with sleep allowed only during a 5.5-hour bedtime period at night

8.5-hour bedtime

Other

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

Primary outcomes

  1. Total energy expenditure

    Time frame: during each bedtime intervention

Secondary outcomes

  1. Physical activity related energy expenditure

    Time frame: during each bedtime intervention

  2. Total body insulin sensitivity

    Time frame: at the end of each bedtime intervention

  3. First and second phase insulin secretion

    Time frame: at the end of each bedtime intervention

  4. Endogenous glucose production

    Time frame: at the end of each bedtime intervention

  5. Glycerol turnover and free fatty acid concentration

    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 29, 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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