Trial Outcomes & Findings for Sleep Duration in Women With Previous Gestational Diabetes (NCT NCT03638102)

NCT ID: NCT03638102

Last Updated: 2024-11-25

Results Overview

Changes in fasting glucose between baseline and 6 weeks

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-11-25

Participant Flow

Participant milestones

Measure	Sleep Intervention Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching	Healthy Living Health education Healthy living: Participants will receive weekly health education
Overall Study STARTED	12	6
Overall Study COMPLETED	9	5
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sleep Intervention n=12 Participants Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching	Healthy Living n=6 Participants Health education Healthy living: Participants will receive weekly health education	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	6 Participants n=6 Participants	18 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=18 Participants
Age, Continuous	41.9 years STANDARD_DEVIATION 2.6 • n=12 Participants	38.7 years STANDARD_DEVIATION 6 • n=6 Participants	40.8 years STANDARD_DEVIATION 3.9 • n=18 Participants
Sex: Female, Male Female	12 Participants n=12 Participants	6 Participants n=6 Participants	18 Participants n=18 Participants
Sex: Female, Male Male	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	6 participants n=6 Participants	15 participants n=18 Participants
Sleep duration	369 minutes STANDARD_DEVIATION 31 • n=12 Participants • one person dropped out	408 minutes STANDARD_DEVIATION 90 • n=5 Participants • one person dropped out	383 minutes STANDARD_DEVIATION 33 • n=17 Participants • one person dropped out
fasting glucose	102.3 mg/dL STANDARD_DEVIATION 12.9 • n=12 Participants • one person dropped out	96.4 mg/dL STANDARD_DEVIATION 3.8 • n=5 Participants • one person dropped out	100.2 mg/dL STANDARD_DEVIATION 10.8 • n=17 Participants • one person dropped out

PRIMARY outcome

Timeframe: 6 weeks

Changes in fasting glucose between baseline and 6 weeks

Outcome measures

Measure	Healthy Living n=5 Participants Health education Healthy living: Participants will receive weekly health education	Sleep Intervention n=9 Participants Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
Changes in Fasting Glucose	10.4 mg/dL Standard Deviation 8.2	1.6 mg/dL Standard Deviation 9.4

PRIMARY outcome

Timeframe: baseline and 6 weeks

Changes in sleep duration from baseline to 6 weeks

Outcome measures

Measure	Healthy Living n=5 Participants Health education Healthy living: Participants will receive weekly health education	Sleep Intervention n=9 Participants Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
Sleep Duration Change	-9.1 minutes Standard Deviation 20.4	26.9 minutes Standard Deviation 42.5

SECONDARY outcome

Timeframe: baseline and 6 weeks

HOMA-IR change at week 0 to week 6. This is an index of fasting insulin resistance, and the higher reflects greater insulin resistance. Generally, a value greater than 2 is suggestive of insulin resistance

Outcome measures

Measure	Healthy Living n=9 Participants Health education Healthy living: Participants will receive weekly health education	Sleep Intervention n=5 Participants Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
HOMA-IR Change	0.7 index Standard Deviation 1.4	0.59 index Standard Deviation 1.08

SECONDARY outcome

Timeframe: Baseline and week 6

Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)

Outcome measures

Measure	Healthy Living n=5 Participants Health education Healthy living: Participants will receive weekly health education	Sleep Intervention n=9 Participants Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
Change in Subjective Sleep Quality	-2.0 Score on a scale Standard Deviation 4.2	-2.8 Score on a scale Standard Deviation 3.2

Adverse Events

Healthy Living

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sleep Intervention

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

Sirimon Reutrakul

University of Illinois Chicago

Phone: 3124135357

Email: sreutrak@uic.edu

Results disclosure agreements

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