A Real-World Study on Changes in Sleep Apnea Among Patients With Type 2 Diabetes/Obesity and Comorbid OSA After Short-Term Treatment With Semaglutide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in Apnea-Hypopea Index (AHI)
研究概览
简要总结
Semaglutide (a GLP-1RA) is approved for type 2 diabetes mellitus T2DM and obesity, but its effect on obstructive sleep apnea OSA remains unclear.
To evaluate changes in Apnea-Hypopnea Index (AHI) after 1-week and 4-week semaglutide treatment in T2DM/obesity patients with OSA, we conducted a single-center real-world study (RWS) of 15 patients. Outcomes assessed included AHI, weight, BMI, blood pressure, blood glucose (fasting blood glucose, glycated albumin), liver function, blood lipids, waist circumference, and other metabolic parameters, to provide real-world evidence for semaglutide in OSA management.
详细描述
- Background Obesity (BMI ≥27 kg/m²) affects over 2.2 billion adults globally and exacerbates comorbidities including cardiovascular disease(CVD), obstructive sleep apnea (OSA) and type 2 diabetes mellitus (T2DM). Semaglutide, a GLP-1 receptor agonist (GLP-1RA), demonstrates significant weight loss (5-20% at 2.4 mg/week) and metabolic benefits in trials. Emerging evidence suggests it may improve OSA by reducing central respiratory dysregulation. However, real-world data on its short-term effects on AHI remain scarce.
- Objectives Primary: Assess change in apnea-hypopnea index (AHI) after 1-week semaglutide treatment.
Secondary:
Change in AHI after 4-week semaglutide treatment; Changes in weight, BMI, waist circumference, blood pressure, glucose (fasting glucose, glycated albumin), liver function, and lipids after 1-week and 4-week semaglutide treatment. 3. Study Design Type: Single-center observational real-world study. Data Source: Structured electronic medical records (EMR) from Fengxian Central Hospital. 4. Study Population 4.1 Inclusion Criteria:
(1) Age 18-65 years. (2) BMI ≥27 kg/m²,with ≥1 comorbidity (hypertension, dyslipidemia, CVD) or T2DM.
(3) On the basis of dietary control and exercise, the therapeutic effect is not satisfactory. There are indications for the use of semaglutide in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 18-65 years.
- •BMI ≥27 kg/m²,with ≥1 comorbidity (hypertension, dyslipidemia, CVD) or T2DM.
- •On the basis of dietary control and exercise, the therapeutic effect is not satisfactory. There are indications for the use of semaglutide in clinical practice.
- •4. Combined with obstructive sleep apnea syndrome.
- •Within the past month, no hormone drug treatment that affects glucose and lipid metabolism, nor any drugs such as antibiotics that significantly interfere with the oral flora, or bariatric surgery has been received.
- •6. With complete information for this study.
排除标准
- •Abnormal weight gain caused by endocrine diseases (pituitary/adrenal diseases, such as Cushing's syndrome; Or hypothyroidism, etc.)
- •Severe renal/hepatic impairment (eGFR <45 mL/min; ALT/AST >2.5×ULN).
- •Severe metabolic diseases, such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, etc.
- •Patients with type 1 diabetes or other special types of diabetes, patients with type 2 diabetes with severely impaired pancreatic islet function, or patients with type 2 diabetes who use insulin.
- •There is a known history of drug use that affects glycolipid metabolism within three months, such as ① glucocorticoids; ② Fluoroquinolone antibiotics; ③ Beta-blockers such as metoprolol, etc. ④ Thyroid preparations such as thyroid hormone tablets; ⑤ Psychotropic drugs, including antipsychotic drugs such as chlorpromazine and olanzapine, as well as anti-anxiety or anti-depression drugs like SSRIS and NaSSAs; ⑥ SABA bronchodilators such as salbutamol and terbutaline; ⑦ Other known drugs that affect glycolipid metabolism, such as statins.
- •Severe bleeding tendency, urinary and reproductive system infections; There are contraindications for the use of semaglutide, such as a history of acute or chronic pancreatitis, medullary thyroid carcinoma, and multiple endocrine neoplasia (MEN) type
- •Patients with contraindications to radiological examinations.
- •Patients with advanced malignant tumors.
- •Severe cardiovascular and cerebrovascular diseases, such as heart failure, etc.
- •Rheumatic immune diseases, etc.
- •Pregnant women and lactating women.
- •Patients who have taken or are currently taking diuretics such as loop diuretics and thiazides within the past month.
- •Currently involved in other interventional researchers.
- •Other situations that the researchers consider unsuitable for the study, such as poor compliance, etc.
研究组 & 干预措施
Semaglutide Treatment Group
single-arm cohort of 15 patients with T2DM/obesity and OSA receiving semaglutide (0.25-2.4mg/week) for 4 weeks
干预措施: Semaglutide Subcutaneous Injection (Drug)
结局指标
主要结局
Changes in Apnea-Hypopea Index (AHI)
时间窗: Baseline and 1 week
Absolute change in AHI from baseline to 1 week after semaglutide treatment
Changes in Apnea-Hypopea Index(AHI)
时间窗: Baseline and 1 week
Absolute change in AHI from baseline to 1 week after semaglutide treatment
次要结局
- Changes in weight(Baseline, 1 week, 4 weeks)
- Changes in BMI(Baseline, 1 week, 4 weeks)
- Changes in waist circumference(Baseline, 1 week, 4 weeks)
- Changes in blood pressure(Baseline, 1 week, 4 weeks)