Investigation of vascular function and structural changes in obese adults with obstructive sleep apnea and type 2 diabetes mellitus

Recruiting

• Conditions: obstructive sleep apnea (OSA) alone and type 2 Diabetes Mellitus (T2DM) alone, OSA combined T2DM and healthy control group; obstructive sleep apnea, type 2 Diabetes Mellitus, vascular function, Flowmedieted dilation, Carotid intima thickness, High intensity interval training

• Registration Number: TCTR20230829002
• Lead Sponsor: CMU Presidential Scholarship

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-29
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1) Subjects with BMI more than or equal to 25 kg/m2 will be defined as obese in the groups of OSA combined T2DM, OSA alone, and T2DM alone, while those with BMI less than 25 kg/m2 will be served as a CON group according to Asian criteria
2) Subjects will have no history of other sleep disorders, asthma, and no history of home CPAP use
3) Subjects with OSA will be newly diagnosed and defined with an apnea-hypotonia index (AHI) more than or equal to 15 events/h with a 30% reduction of flow and 4% desaturation and subjects with OSA-free will be defined as AHI is less than 5 based on the criteria of Hudgel et al.
4) Subjects with T2DM will be defined when FBG more than or equal to 126 mg/dL or use of glycaemic medication, while non-T2DM will be defined as FBG less than 126 mg/dL and glycated hemoglobin less than 6.5 % based on the American Diabetes Association criteria. This information will be obtained by blood sampling.
5) OSA with the T2DM group will meet the criteria for both OSA and T2DM
6) Control group will be healthy with no OSA and T2DM and no family history of T2DM

Exclusion Criteria

1) Subjects have diseases or illnesses that affect the breathing disorders and vasculature results including cardiovascular disease, liver disease, renal disease, pulmonary disease, peripheral arterial disease, stroke, or transient ischemic attack
2) Subjects use cigarette smoking in the previous 6 months
3) Subjects receive medications, which will not involve usual care and may affect vascular function and/ or structure such as hypnotic and sedative medications

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow medieted dilation Baseline, every 30 seconds after cuff release until 2 minutes Ultrasound Machine ,Carotid Intima Media thickness 3 times of scanning of left and right side Ulrasound Mechine (mm.)

Secondary Outcome Measures

Name	Time	Method
Risk factors at 12 months Questionnaire interviews (lifestyle, family history, clinical history, nutrition, patient health questionnaire-9 (PHQ-9), patient health questionnaire-2 (PHQ-2), stress test questionnaire (ST-5) )