Effects of Sleep Duration and Architecture on Insulin Sensitivity
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep restriction
Sponsored by
About this trial
This is an interventional diagnostic trial for Insulin Resistance focused on measuring Diabetes
Eligibility Criteria
Inclusion Criteria:
- Age 18-45 years
- Regular work hours (ie, no night-time or shift work within the past 6 months)
- Pittsburgh Sleep Quality Index (PSQI) Score <5
- Average nightly sleep duration 6-9 hours (per screening actigraphy)
Exclusion Criteria:
- Current or prior diabetes, gestational diabetes, impaired glucose tolerance or impaired fasting glucose
- Type 2 diabetes in biological parents
- BMI >=25
- Pregnancy
- Chronic medical condition, including: psychiatric disorders, heart disease, pulmonary disease, infectious diseases, rheumatological and neurological disorders
- Use of prescribed medications on a regular basis.
- History of disorder involving hypothalamic, pituitary or adrenal glands
- History of or current sleep disorders (insomnia, restless leg syndrome, sleep disordered breathing, narcolepsy, etc)
- Anemia
- Cognitive impairment
Sites / Locations
- UCSF San Francisco General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sleep restriction
Arm Description
The investigators will compare the effects of sleep restriction vs. normal sleep in healthy volunteers, using a randomized crossover study design. Each subject will undergo a period of normal sleep and a period of sleep restriction, separated by a 1-month washout period. Subjects will be randomized to receive either sleep restriction first (later followed by normal sleep) or normal sleep first (later followed by sleep restriction).
Outcomes
Primary Outcome Measures
Insulin sensitivity
Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.
Secondary Outcome Measures
Full Information
NCT ID
NCT01396941
First Posted
July 15, 2011
Last Updated
July 13, 2021
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01396941
Brief Title
Effects of Sleep Duration and Architecture on Insulin Sensitivity
Official Title
Effects of Sleep Duration and Architecture on Insulin Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to "normal sleep", will:
Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.
Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.
Detailed Description
Over the past 50 years, the incidence of diabetes has increased dramatically, while sleep duration in the US has decreased significantly. Epidemiological studies and small clinical trials suggest that these trends are causally related. In this study, our goal is to determine the mechanisms by which decreased sleep duration directly affects insulin sensitivity. The investigators will perform a clinical study in 20 healthy volunteers to determine whether 5 nights of sleep restriction decreases insulin sensitivity in the peripheral tissues (ie, skeletal muscle) or liver.
Peripheral insulin sensitivity will be measured by the hyperinsulinemic-euglycemic clamp, and hepatic insulin sensitivity will be quantified by measurement of hepatic glucose production, gluconeogenesis and glycogenolysis (using stable isotope tracer methods). Subjects will be randomized to an initial period of "normal sleep" or sleep restriction and will be admitted to the Clinical Research Center (CRC) for 9 days to undergo comprehensive metabolic studies and sleep assessments under the assigned sleep condition. After a 1-month washout period, subjects will be re-admitted to the CRC to undergo these same assessments under the opposite sleep condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleep restriction
Arm Type
Experimental
Arm Description
The investigators will compare the effects of sleep restriction vs. normal sleep in healthy volunteers, using a randomized crossover study design. Each subject will undergo a period of normal sleep and a period of sleep restriction, separated by a 1-month washout period. Subjects will be randomized to receive either sleep restriction first (later followed by normal sleep) or normal sleep first (later followed by sleep restriction).
Intervention Type
Behavioral
Intervention Name(s)
Sleep restriction
Intervention Description
Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-45 years
Regular work hours (ie, no night-time or shift work within the past 6 months)
Pittsburgh Sleep Quality Index (PSQI) Score <5
Average nightly sleep duration 6-9 hours (per screening actigraphy)
Exclusion Criteria:
Current or prior diabetes, gestational diabetes, impaired glucose tolerance or impaired fasting glucose
Type 2 diabetes in biological parents
BMI >=25
Pregnancy
Chronic medical condition, including: psychiatric disorders, heart disease, pulmonary disease, infectious diseases, rheumatological and neurological disorders
Use of prescribed medications on a regular basis.
History of disorder involving hypothalamic, pituitary or adrenal glands
History of or current sleep disorders (insomnia, restless leg syndrome, sleep disordered breathing, narcolepsy, etc)
Anemia
Cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhu N. Rao, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
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Effects of Sleep Duration and Architecture on Insulin Sensitivity
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