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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724087
First received: July 25, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Sleep
Sleep Deprivation
Insulin Resistance
Type 2 Diabetes
Other: 5.5-hour bedtime
Other: 8.5-hour bedtime

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sleep, Energy Metabolism and Diabetes Risk.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Total energy expenditure [ Time Frame: during each bedtime intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity related energy expenditure [ Time Frame: during each bedtime intervention ] [ Designated as safety issue: No ]
  • Total body insulin sensitivity [ Time Frame: at the end of each bedtime intervention ] [ Designated as safety issue: No ]
  • First and second phase insulin secretion [ Time Frame: at the end of each bedtime intervention ] [ Designated as safety issue: No ]
  • Endogenous glucose production [ Time Frame: at the end of each bedtime intervention ] [ Designated as safety issue: No ]
  • Glycerol turnover and free fatty acid concentration [ Time Frame: at the end of each bedtime intervention ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5.5-hour bedtime Other: 5.5-hour bedtime
16 days with sleep allowed only during a 5.5-hour bedtime period at night
Experimental: 8.5-hour bedtime Other: 8.5-hour bedtime
16 days with sleep allowed only during a 8.5-hour bedtime period at night

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724087

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Plamen D Penev, MD, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724087     History of Changes
Other Study ID Numbers: 16079A-S4, R01HL089637
Study First Received: July 25, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
short sleep duration
energy expenditure
insulin secretion
insulin action
lipid turnover
free fatty acids

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Sleep Deprivation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014