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Sleep Apnea and Gestational Diabetes

Primary Purpose

Gestational Diabetes, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Continuous positive airway pressure (S9, ResMed)
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational diabetes

Exclusion Criteria:

  • pre-gestational diabetes

Sites / Locations

  • Faculty of Medicine Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP Intervention

Wait-list

Arm Description

Continuous positive airway pressure (S9, ResMed)

Wait list controls

Outcomes

Primary Outcome Measures

glucose tolerance
Measuring glucose, fructosamine and insulin levels following a mixed meal test at 0 and 2 weeks. Glucose and insulin will be measured at 0 minutes and every 30 minutes thereafter for 2 hours. Fructosamine will be measured at 0 minutes only.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2014
Last Updated
January 17, 2018
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02108197
Brief Title
Sleep Apnea and Gestational Diabetes
Official Title
Obstructive Sleep Apnea and Gestational Diabetes : Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP Intervention
Arm Type
Experimental
Arm Description
Continuous positive airway pressure (S9, ResMed)
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
Wait list controls
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (S9, ResMed)
Primary Outcome Measure Information:
Title
glucose tolerance
Description
Measuring glucose, fructosamine and insulin levels following a mixed meal test at 0 and 2 weeks. Glucose and insulin will be measured at 0 minutes and every 30 minutes thereafter for 2 hours. Fructosamine will be measured at 0 minutes only.
Time Frame
two weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational diabetes Exclusion Criteria: pre-gestational diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirimon Reutrakul, MD
Organizational Affiliation
Faculty of Medicine Ramathibodi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29458699
Citation
Chirakalwasan N, Amnakkittikul S, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Thakkinstian A, Reutrakul S. Continuous Positive Airway Pressure Therapy in Gestational Diabetes With Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2018 Mar 15;14(3):327-336. doi: 10.5664/jcsm.6972.
Results Reference
derived

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Sleep Apnea and Gestational Diabetes

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