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Sleep Duration in Women With Previous Gestational Diabetes

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep extension
Healthy living
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring sleep duration, glucose metabolism

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes
  • At least one year post-partum
  • Reported habitual sleep duration <7h/night during work- or weekdays with a desire to sleep longer
  • Reported time spent in bed =<8 hours
  • Own a smartphone compatible with Fitbit.
  • No need to provide care at night for her child(ren), defined as >3 times a week and >30 minutes at a time
  • No history of obstructive sleep apnea, insomnia, or restless leg syndrome

Exclusion Criteria:

  • A1C ≥6.5%
  • Currently pregnant or planning pregnancy or breast feeding
  • Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15)
  • Rotating shift or night shift work
  • High risk for obstructive sleep apnea screened by STOP BANG questionnaire.
  • Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep intervention

Healthy living

Arm Description

Sleep extension

Health education

Outcomes

Primary Outcome Measures

Changes in Glucose metabolism parameters
Changes in serum glucose and insulin levels from oral glucose tolerant test (at 0,30,60,90 and 120 minutes) between baseline and 6 weeks
Sleep duration
Changes in sleep duration from baseline to 6 weeks

Secondary Outcome Measures

Glucose metabolism post intervention
Fasting glucose and insulin
Energy metabolism post intervention
Weight and caloric intake
Subjective sleep quality
Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)
Energy metabolism
Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks
Depressive symptoms
Center for Epidemiologic Studies Depression Scale (range 0-60 with higher score reflecting more depressive symptoms)

Full Information

First Posted
August 12, 2018
Last Updated
September 27, 2021
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03638102
Brief Title
Sleep Duration in Women With Previous Gestational Diabetes
Official Title
The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Women with a history of gestational diabetes (GDM) are at high risk of developing diabetes in the future. Sleep disturbances are emerging as risk factors for incident diabetes. The purpose of this study is to test the effects of 6-week sleep extension in women with a history of GDM and short sleep on glucose metabolism by randomized controlled study.
Detailed Description
The primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of GDM and habitual short sleep duration on the outcomes of glucose metabolism. The participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. Glucose metabolism parameters will be assessed by an oral glucose tolerant test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
sleep duration, glucose metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep intervention
Arm Type
Experimental
Arm Description
Sleep extension
Arm Title
Healthy living
Arm Type
Active Comparator
Arm Description
Health education
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension
Intervention Description
Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
Intervention Type
Behavioral
Intervention Name(s)
Healthy living
Intervention Description
Participants will receive weekly health education
Primary Outcome Measure Information:
Title
Changes in Glucose metabolism parameters
Description
Changes in serum glucose and insulin levels from oral glucose tolerant test (at 0,30,60,90 and 120 minutes) between baseline and 6 weeks
Time Frame
6 weeks
Title
Sleep duration
Description
Changes in sleep duration from baseline to 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Glucose metabolism post intervention
Description
Fasting glucose and insulin
Time Frame
10 weeks (4 weeks post intervention)
Title
Energy metabolism post intervention
Description
Weight and caloric intake
Time Frame
10 weeks (4 weeks post intervention)
Title
Subjective sleep quality
Description
Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)
Time Frame
Baseline, week 6 and week 10
Title
Energy metabolism
Description
Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks
Time Frame
6 weeks
Title
Depressive symptoms
Description
Center for Epidemiologic Studies Depression Scale (range 0-60 with higher score reflecting more depressive symptoms)
Time Frame
Baseline, week 6 and week 10

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Non-diabetic women with a previous history of gestational diabetes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes At least one year post-partum Reported habitual sleep duration <7h/night during work- or weekdays with a desire to sleep longer Reported time spent in bed =<8 hours Own a smartphone compatible with Fitbit. No need to provide care at night for her child(ren), defined as >3 times a week and >30 minutes at a time No history of obstructive sleep apnea, insomnia, or restless leg syndrome Exclusion Criteria: A1C ≥6.5% Currently pregnant or planning pregnancy or breast feeding Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15) Rotating shift or night shift work High risk for obstructive sleep apnea screened by STOP BANG questionnaire. Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirimon Reutrakul, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19465232
Citation
Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.
Results Reference
background
PubMed Identifier
10543671
Citation
Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.
Results Reference
background
PubMed Identifier
24628249
Citation
Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14.
Results Reference
background
PubMed Identifier
29546578
Citation
Amnakkittikul S, Chirakalwasan N, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Reutrakul S. Postpartum resolution of obstructive sleep apnea in women with gestational diabetes and the relationship with glucose metabolism. Acta Diabetol. 2018 Jul;55(7):751-754. doi: 10.1007/s00592-018-1127-x. Epub 2018 Mar 15. No abstract available.
Results Reference
background
PubMed Identifier
29321122
Citation
Baron KG, Duffecy J, Reid K, Begale M, Caccamo L. Technology-Assisted Behavioral Intervention to Extend Sleep Duration: Development and Design of the Sleep Bunny Mobile App. JMIR Ment Health. 2018 Jan 10;5(1):e3. doi: 10.2196/mental.8634.
Results Reference
background
PubMed Identifier
23990896
Citation
Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.
Results Reference
background
PubMed Identifier
35659776
Citation
Reutrakul S, Martyn-Nemeth P, Quinn L, Rydzon B, Priyadarshini M, Danielson KK, Baron KG, Duffecy J. Effects of Sleep-Extend on glucose metabolism in women with a history of gestational diabetes: a pilot randomized trial. Pilot Feasibility Stud. 2022 Jun 4;8(1):119. doi: 10.1186/s40814-022-01076-2.
Results Reference
derived

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Sleep Duration in Women With Previous Gestational Diabetes

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