Glucose Metabolism and Sleep 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:
NCT00720889
First received: July 21, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 individual differences in habitual sleep duration may be related to differences in the carbohydrate metabolism of people who have a history of type 2 diabetes in their family.


Condition
Sleep
Insulin Resistance
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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 body insulin sensitivity [ Time Frame: at the end of a 4-hour hyperinsulinemic clamp ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First and second phase insulin secretion [ Time Frame: during a 3-hour hyperglycemic clamp ] [ Designated as safety issue: No ]
  • Endogenous glucose production [ Time Frame: before and during a 4-hour hyperinsulinemic clamp ] [ Designated as safety issue: No ]
  • Glycerol turnover and free fatty acid concentration [ Time Frame: before and during a 4-hour hyperinsulinemic clamp ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reduced sleep
Habitual sleep duration of less than 6 hours per night on most days of the week and total sleep of less than 43 hours per week.
Reference sleep
Habitual sleep duration between 7 and 8.5 hours per night on most days of the week and total sleep of at least 53 hours per week.

Detailed Description:

On two consecutive inpatient days, the participants in this study will undergo two different tests. The first test will determine how much insulin can their body produce in response to an intravenous glucose infusion over a period of 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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy non-obese community-living men and women with a parent, sibling or grandparent who has type 2 diabetes

Criteria

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
  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: NCT00720889

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: NCT00720889     History of Changes
Other Study ID Numbers: 16079A-S2, R01HL089637
Study First Received: July 21, 2008
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
short sleep duration
glucose clamp technique
insulin secretion
insulin action
lipid turnover
free fatty acids

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on August 28, 2014