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Therapeutic Areas: Neurology | Psychiatry/Psychology
Disease Category: Sleep Disorders

Trial Information

Do you have Type 2 Diabetes? Are you tired? The GLYCOSA Study is assessing the effectiveness of Positive Airway Pressure (PAP) for glucose control in patients with Type 2 Diabetes Mellitus and Sleep Apnea.

Study Title: Effect of n-CPAP Treatment on Glycemic Control in patients with Type 2 Diabetes Mellitus and Obstructive Sleep Apnea -- GLYCOSA Study

This study examines the relationship between the use of Positive Airway Pressure (PAP) for sleep apnea and whether it will improve glucose (blood sugar) control. Sleep apnea is a condition where a person has periods of shallow or no breathing during sleep. Over time, this can have serious consequences on a person's health. Research has shown that about one third of patients with Type 2 Diabetes also have sleep apnea. Current research indicates that patients with Type 2 Diabetes who receive treatment for their sleep apnea may show significant improvement in their blood sugar control.

This study has 2 phases: Phase 1 identifies people who have sleep apnea and requires two study visits. This includes a sleep evaluation, an overnight sleep study and analysis of blood sugar level and blood pressure status. Phase 2 evaluates the effect of PAP on blood sugar control. In this phase, participants will be randomized into either a PAP treatment group or a Control group. Standard lifestyle counseling, which uses the American Diabetes Association recommendations on nutrition and exercise, will be provided. Monthly follow-up visits include assessment of the healthy lifestyle approach for all study participants, and additional blood and urine sampling for the duration of the 6 month trial period.

Research subjects will be compensated for time and effort.

INCLUSION CRITERIA

• Adult patients, 18 or older;
• Type 2 Diabetes Mellitus;
• Not using insulin;
• BMI ≤ 40;
• On stable medications for last 3 months;
• Systolic BP less than or equal to 150 mmHg;
• Willingness to give written informed consent and able to come to scheduled visits

EXCLUSION CRITERIA

• Previous diagnosis for sleep apnea;
• Insulin requiring;
• Concurrent participation in another clinical trial;
• Work in a transportation-related industry, e.g., truck driver

Johns Hopkins University
Professional Arts Building
5 Public Square
Hagerstown, MD 21740
Phone: (301) 791-1847
EMail: mminotti@jhsph.edu

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