Trial Outcomes & Findings for Home Sleep and Circadian Phase: Mediators of Diabetes Risk (NCT NCT01786564)

NCT ID: NCT01786564

Last Updated: 2020-11-27

Results Overview

The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: baseline
• Results posted on: 2020-11-27

Participant Flow

Of 120 participants enrolled in the study, 56 were eligible, continued in the study and provided some data.

Participant milestones

Measure	Study Sample This is a cross-sectional study so there is only one group.
Overall Study STARTED	120
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Measure	Study Sample This is a cross-sectional study so there is only one group.
Overall Study Lost to Follow-up	47
Overall Study Ineligible	17

Baseline Characteristics

Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures.

Baseline characteristics by cohort

Measure	Study Sample n=56 Participants This is a cross-sectional study so there is only one group.
Age, Categorical <=18 years	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=56 Participants
Age, Categorical >=65 years	0 Participants n=56 Participants
Age, Continuous	30 years STANDARD_DEVIATION 8.4 • n=56 Participants
Sex: Female, Male Female	29 Participants n=56 Participants
Sex: Female, Male Male	27 Participants n=56 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=56 Participants
Race (NIH/OMB) Asian	0 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	27 Participants n=56 Participants
Race (NIH/OMB) White	29 Participants n=56 Participants
Race (NIH/OMB) More than one race	0 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants
Region of Enrollment United States	56 participants n=56 Participants
Body Mass Index (BMI), kg/m2	27.7 kg/m2 STANDARD_DEVIATION 5.3 • n=56 Participants
Habitual Sleep Duration (hours)	402 minutes STANDARD_DEVIATION 39 • n=53 Participants • Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures.
Habitual sleep efficiency (% of sleep period sleeping)	90.8 percentage STANDARD_DEVIATION 3.5 • n=53 Participants • Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures.
Habitual sleep start time (clock time)	0.27 Hours after midnight STANDARD_DEVIATION 1.51 • n=53 Participants • Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures.
Duration of Stage 2 sleep (minutes)	190.6 Minutes STANDARD_DEVIATION 77.4 • n=51 Participants • Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data.
Duration of Stage 3 sleep (minutes)	68.4 Minutes STANDARD_DEVIATION 30.7 • n=51 Participants • Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data.
Duration of Rapid Eye Movement (REM) sleep (minutes)	96.5 Minutes STANDARD_DEVIATION 49.1 • n=51 Participants • Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data.
Fasting glucose levels (mg/dl)	86.8 mg/dl STANDARD_DEVIATION 6.3 • n=54 Participants • 2 participants were missing valid fasting blood samples so only 54 have a HOMA measure.
Estimated Insulin Resistance (HOMA index method)	1.75 None (Index) STANDARD_DEVIATION 1.82 • n=54 Participants • 2 participants were missing valid fasting blood samples so only 54 participants have HOMA estimated.
Oral Disposition Index at 30 minutes	11.5 None (Index) STANDARD_DEVIATION 12.7 • n=53 Participants • 3 participants were missing some blood samples so the oral disposition index could not be calculated in these 3 participants. Thus, only 53 participants have this measure.

PRIMARY outcome

Timeframe: baseline

Population: Three participants did not have adequate glucose and/or insulin values to calculate the disposition index.

The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.

Outcome measures

Measure	Study Sample n=53 Participants This is a cross-sectional study so there is only one group.
Oral Disposition Index	11.5 None (Index) Standard Deviation 12.7

Adverse Events

Study Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristen Knutson

Northwestern University

Phone: 312-503-1526

Email: kristen.knutson@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place