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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583750
Other study ID # Pro00032421
Secondary ID
Status Completed
Phase N/A
First received October 15, 2015
Last updated October 20, 2015
Start date January 2014
Est. completion date September 2014

Study information

Verified date October 2015
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This project investigated how glucose metabolism differs due to sleep deprivation for three consecutive nights as compared to sufficient sleep for three nights by examining concentrations of glucose, insulin, and other factors involved in glucose metabolism.


Description:

16 participants were enrolled in the study (8 females, 8 males) aged 18-25 years. In order for the participants to qualify for the study, each had to wear a pedometer for a week before the study began to determine eligibility. Each participant came to the lab for an oral glucose tolerance test on a morning, following three nights when they were sleep deprived, and on another morning when they had three nights' sufficient sleep. The sequence of the oral glucose tolerance tests were randomly assigned. The sleep duration for participants was monitored by the readings of the sleep monitors that each participant wore. The oral glucose tolerance tests were performed after an overnight fast. A 20-gauge polyethylene catheter was placed in the antecubital vein for blood sampling. Blood samples were drawn once (0 min) before and 4 times (30, 60, 90, and 120 min) after a 75g glucose drink was consumed for the determination of plasma glucose, insulin, and concentrations of other factors. Each participant was told to continue their regular routine during the study period, including diet, caffeine usage, and exercise.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- healthy college-aged males and females

- being minimally active

Exclusion Criteria:

- average more than 15,000 steps a day

- major health issues such as heart disease, diabetes

- taking medication to help with sleep or using a sleeping device

- any type of sleep problem such as sleep apnea

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Behavioral:
OGTT after deprived sleep first
Participants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights.
OGTT after sufficient sleep first
Participants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights.

Locations

Country Name City State
United States Public Health Research Center University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Xuewen Wang

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose concentrations during oral glucose tolerance test two hours No
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