Sleep Apnea and Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Obstructive Sleep Apnea and Gestational Diabetes : Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108197
• Other study ID #: 11-56-39
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: January 17, 2018
• Start date: April 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2018
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• gestational diabetes

Exclusion Criteria:

• pre-gestational diabetes

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Continuous positive airway pressure (S9, ResMed)

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two weeks