High intensity interval training on vascular function and structure in obese adults with obstructive sleep apnea and Type 2 Diabetes Mellitus

Phase 1

Recruiting

• Conditions: Obese adults with obstructive sleep apnea and Type 2 Diabetes Mellitus; obstructive sleep apnea; Type 2 Diabetes Mellitus; High intensity interval training; vascular function; Vascular structure

• Registration Number: TCTR20230821002
• Lead Sponsor: presidential scholarship, Chiang Mai university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Participants with obesity BMI more than or equal to 25 (kg/m2), according to Asian criteria
2) Participants who have no history of other sleep disorders, asthma, and no history of home CPAP use before participating in the study
3) Participants who are newly diagnosed to be OSA and OSA-free, based on the criteria of Hudgel et al.
4) Participants who are diagnosed for T2DM based on the American Diabetes Association criteria
5) Participants who are free from diabetic nephropathy, diabetic retinopathy, severe diabetic neuropathy, and severe cardiovascular and cerebrovascular diseases
6) Participants who are not physically active (less than 1 hr/week) for at least 3 months
7) Participants who have not receive nutritional supplements, CPAP, and other exercise programs, which may affect the study results in the previous 3 months

Exclusion Criteria

1) Participants who have other 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) Participants who have used cigarette smoking in the previous 6 months
3) Participants who receive medications, which will not involve usual care and may affect vascular function and/ or structure such as hypnotic and sedative medications
4) Participants who have fasting blood glucose more than or equal to 13.9 mmol/L (250 mg/dL), HbA1c more than or equal to 10% (86 mmol/mol)
5) Participants who have blood pressure (BP) greater than 180/110 mmHg or greater than 160/110 mmHg for people on antihypertensive medication
6) Participants who have triglyceride to HDL-C ratio more than 3.9
7) Participants who have variations of weight for 5 kg. in three months
8) Participants are unable to exercise such as having medical conditions or musculoskeletal injuries that limit exercise ability
9) Participants who have contraindications for exercise such as dyspnea at rest, severe hypertension, and acute joint inflammation etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow-medieted dilation Before and after 12 weeks Ultrasound Machine,Carotid intima media thickness Before and after 12 weeks Ultrasond Machine

Secondary Outcome Measures

Name	Time	Method
Sleep indices score before and after 12 weeks Polysomnography ,HbA1C before and after 12 weeks %,Lipid profiles before and after 12 weeks mg/d