NCT00915707

Brief Summary

This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

5.5 years

First QC Date

June 3, 2009

Last Update Submit

September 4, 2013

Conditions

ObesityDiabetes

Keywords

obesitydiabetes, riskobesity, diabetes risk related to sleep

Outcome Measures

Primary Outcomes (1)

  • Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality.

    3 months

Study Arms (3)

Baseline

EXPERIMENTAL

Subjects are tested under normal sleep conditions for carbohydrate metabolism and appetite regulation.

Other: Baseline

Sleep restriction

EXPERIMENTAL

Subjects are tested under sleep restriction for carbohydrate metabolism and appetite regulation.

Other: Sleep restriction

Reduced sleep quality

EXPERIMENTAL

Subjects are tested under a poor sleep quality condition for carbohydrate metabolism and appetite regulation.

Other: Reduced Sleep Quality

Interventions

BaselineOTHER

Subjects are allowed time in bed for sleep as their usual time at home.

Baseline
Sleep restrictionOTHER

Subjects sleep is reduced to 4.5 hours in bed for 4 nights.

Sleep restriction
Reduced Sleep QualityOTHER

Subjects sleep quality is reduced for 4 nights.

Reduced sleep quality

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight
  • Healthy
  • Normal sleep times

You may not qualify if:

  • Sleep disorders
  • Overweight
  • Diabetes
  • Other health conditions
  • Excessive caffeine and alcohol intake
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Esra Tasali, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 8, 2009

Study Start

January 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)