Semaglutide Effects on Sleep Apnea in Patients With Type 2 Diabetes/Obesity and Comorbid Obstructive Sleep Apnea

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndrome (OSAS)
• Intervention / Treatment: Drug: Semaglutide Subcutaneous Injection

Detailed Description

1. 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.

2. 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.

(4) Combined with obstructive sleep apnea syndrome. (5) 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.

4.2 Exclusion Criteria:

1. Abnormal weight gain caused by endocrine diseases (pituitary/adrenal diseases, such as Cushing's syndrome; Or hypothyroidism, etc.)
2. Severe renal/hepatic impairment (eGFR <45 mL/min; ALT/AST >2.5×ULN).
3. Severe metabolic diseases, such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, etc.
4. 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.
5. 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.
6. 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 2.
7. Patients with contraindications to radiological examinations.
8. Patients with advanced malignant tumors.
9. Severe cardiovascular and cerebrovascular diseases, such as heart failure, etc.
10. Rheumatic immune diseases, etc.
11. Pregnant women and lactating women.
12. Patients who have taken or are currently taking diuretics such as loop diuretics and thiazides within the past month.
13. Currently involved in other interventional researchers.
14. Other situations that the researchers consider unsuitable for the study, such as poor compliance, etc.

5. Treatment Records 5.1 Drug: Semaglutide subcutaneous injection. 5.2 Dosing: 1ml of the injection contains 1.34mg of semaglutide. Each pre-filled injection pen contains 2mg of semaglutide and is placed in 1.5ml of solution. This product should be injected once a week. It can be administered at any time of the day without the need to follow meal times. This product is administered by subcutaneous injection. The injection site can be selected from the abdomen, thigh or upper arm. There is no need to adjust the dosage when changing the injection site. In all cases, patients should resume a regular weekly dosing schedule.

5.3 Concomitant Medications: The patient's medical records should detail the situation of concomitant medication during the study period and must comply with the management regulations for the concomitant medication of semaglutide In particular, metformin, sulfonylurea drugs, glucocorticoids, fluoroquinolone antibiotics, beta-blockers such as metoprolol, thyroid preparations such as thyroid hormone tablets, psychotropic drugs, anti-anxiety or anti-depression drugs such as SSRIS and NaSSAs, SABA bronchodilators, and other known drugs that affect glucose and lipid metabolism should be recorded.

6. Endpoints

The study will evaluate the following endpoints:

6.1 Primary Endpoint: Change in AHI measured by PSG from baseline (T0) to 1 week post-treatment (T1).

6.2 Secondary Endpoints:

1. Change in AHI measured by PSG from T0 to 4 weeks post-treatment (T2);
2. Changes in weight (units: kg), from T0 to T1 and 4 weeks post-treatment (T2);
3. Changes in BMI, from T0 to T1 and T2;
4. Waist circumference (units: cm), from T0 to T1 and T2;
5. Blood pressure (units: mmHg), from T0 to T1 and T2;

6. Changes in metabolic markers from T0 to T1 and T2 inlcuding

   • fasting glucose (mmol/L)

     • glycated albumin (%)

       • liver enzymes (U/L)

         ④ lipid profiles (mmol/L)

         7. Statistical Analyses 7.1 Sample Size Estimation 15 patients (80% power, α=0.05, paired Wilcoxon Signed-Rank test; anticipated ΔAHI=-10.58±10 from pilot data).

7.2 Data Handling Missing Data: Patients with missing baseline or follow-up AHI measurements will be excluded from the primary analysis.

Outliers: Values outside the 95% normal range will be reviewed for potential data entry errors or biological plausibility before analysis.

7.3 Primary Analyses The primary endpoint (sleep PSG parameters) was compared with the baseline treatment at 1 week after treatment using the paired t test or the paired rank sum test (depending on whether the data passed normality tests) to assess whether the change was statistically significant. If the P value was less than 0.05, it could be considered that the sleep PSG parameters had decreased after treatment. Other secondary endpoint indicators (sleep PSG parameters, liver function, blood glucose, etc.) were also compared with baseline treatment at 4 weeks after treatment using the paired t test or the paired rank sum test (depending on whether the data passed normality tests) to assess whether the change was statistically significant. If the P value was less than 0.05, it could also be considered that there was a change.

7.4 Secondary Analyses If the dosage of medication for some patients is adjusted during the study period, subgroup analyses will be conducted based on different doses. For instance, if the first dose is 0.25mg and then adjusted to 0.5mg or maintained at 0.25mg, further analysis will be conducted in different subgroups.

7.5 Sensitivity Analyses To assess the stability of the research results, external controls, published data, and data from other patients treated concurrently will be introduced for evaluation, and the differences before and after treatment will be compared. To minimize the impact of outliers, data outside the 95% range will be presented during the analysis to assess the consistency of the results. For some doses that are inconsistent, the results will be evaluated through inclusion and exclusion, and the consistency will be compared.

7.6 Quality control The quality control of this study consists of two parts. The data collected in the retrospective study must ensure the completeness of the data and the consistency of the equipment. The data collected in the prospective study will be subject to quality control on the standardization of the CRF table, the parameters of the equipment, and the operators to avoid measurement errors caused by human or equipment factors.

8. Ethics Approved by Fengxian Central Hospital (IRB No.: 2025-KY-56-02) De-identified EMR data extracted under broad consent for secondary research. Compliance with China's Personal Information Protection Law (PIPL).

9. Timeline Data collection: Jan 2025-Dec 2025. Analysis: Jan 2026. Study completion: 31-Jan-2026.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201499
    • Shanghai Fengxian District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

15 adults with T2DM/obesity and OSA receiving semaglutide

Description

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.

4. Combined with obstructive sleep apnea syndrome. 5. 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. Exclusion Criteria.

1. Abnormal weight gain caused by endocrine diseases (pituitary/adrenal diseases, such as Cushing's syndrome; Or hypothyroidism, etc.)
2. Severe renal/hepatic impairment (eGFR <45 mL/min; ALT/AST >2.5×ULN).
3. Severe metabolic diseases, such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, etc.
4. 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.
5. 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.
6. 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 2.
7. Patients with contraindications to radiological examinations.
8. Patients with advanced malignant tumors.
9. Severe cardiovascular and cerebrovascular diseases, such as heart failure, etc.
10. Rheumatic immune diseases, etc.
11. Pregnant women and lactating women.
12. Patients who have taken or are currently taking diuretics such as loop diuretics and thiazides within the past month.
13. Currently involved in other interventional researchers.
14. Other situations that the researchers consider unsuitable for the study, such as poor compliance, etc.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Semaglutide Treatment Group; single-arm cohort of 15 patients with T2DM/obesity and OSA receiving semaglutide (0.25-2.4mg/week) for 4 weeks

Drug: Semaglutide Subcutaneous Injection; This study is a observational study and the treatments are based on the clinical practice. In the study, patients with treatments were recorded. According to the instructions of drugs, 1ml of the injection contains 1.34mg of semaglutide. Each pre-filled injection pen contains 2mg of semaglutide and is placed in 1.5ml of solution. This product should be injected once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Apnea-Hypopea Index (AHI)	Absolute change in AHI from baseline to 1 week after semaglutide treatment	Baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Absolute change in body weight (kg) from baseline to 1 and 4 weeks.	Baseline, 1 week, 4 weeks
Changes in BMI	Absolute change in BMI (kg/m2) from baseline to 1 and 4 weeks.	Baseline, 1 week, 4 weeks
Changes in waist circumference	Absolute change in waist circumference (cm) from baseline to 1 and 4 weeks.	Baseline, 1 week, 4 weeks
Changes in blood pressure	Absolute change in blood pressure (mmHg) from baseline to 1 and 4 weeks.	Baseline, 1 week, 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting glucose	absolute changes in fasting glucose (mmol/L), from baseline to T1 and T2.	Baseline, 1 week, 4 weeks
Changes in glycated albumin	absolute changes in glycated albumin (%), from baseline to T1 and T2.	Baseline, 1 week, 4 weeks
Changes in liver enzymes	absolute changes in liver enzymes (U/L), from baseline to T1 and T2.	Baseline, 1 week, 4 weeks
Changes in lipid profiles	absolute changes in lipid profiles (mmol/L), including total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol from baseline to T1 and T2.	Baseline, 1 week, 4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Fengxian District Central Hospital

Publications and helpful links

Helpful Links

• World Obesity Atlas 2024 | World Obesity Federation[EB/OL]. [2024-10-28]

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Semaglutide; Type 2 Diabetes; metabolic syndrome; AHI; GLP-1 receptor agonist; real-world study
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Insulin Resistance; Hyperinsulinism; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Metabolic Syndrome; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2025-KY-56-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No