Effects of Sleep Duration and Architecture on Insulin Sensitivity

NCT01396941 | Completed

• 1 other identifier: K23HL096832
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to "normal sleep", will:

1. 1.Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.
2. 2.Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.

Conditions

Insulin Resistance

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.

  1 month

Study Arms (1)

sleep restriction

EXPERIMENTAL

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).

Behavioral: Sleep restriction

Interventions

Sleep restriction BEHAVIORAL

Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night

sleep restriction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UCSF San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Madhu N. Rao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 19, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

US (1)