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NCT Number: NCT07513259

Pre-Diagnosis GLP-1 Receptor Agonist Use and Post-Cancer Mortality in Adults With Obesity and Type 2 Diabetes

This study will examine whether the type of diabetes treatment used before cancer diagnosis is associated with survival and serious complications after obesity-associated cancer in adults with obesity and type 2 diabetes. The study focuses on glucagon-like peptide-1 receptor agonists (GLP-1 RA) and compares them with other commonly used glucose-lowering therapies, including SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas, metformin, and usual care. Using de-identified electronic health record data from the TriNetX US Collaborative Network, the study will assess whether patients who used GLP-1 RA before cancer diagnosis have different risks of death, hospitalization, sepsis, and other major outcomes after cancer diagnosis. This is an observational study designed to evaluate associations in routine clinical care and not to prove a treatment effect.

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Key information

Conditions

Obesity & Overweight Body Weight Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung Shan Medical University Hospital

Taichung, Taichung City, 402, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • BMI ≥27 kg/m2, or diagnosis codes consistent with obesity
  • Type 2 diabetes mellitus
  • Initiation of a glucose-lowering medication before obesity-associated cancer diagnosis
  • Incident obesity-associated cancer diagnosed after medication initiation
  • No dispensing of the study drug class during the 6-month washout period before the first qualifying prescription

Exclusion criteria

  • Type 1 diabetes mellitus, Other specified diabetes types that are not type 2 diabetes
  • Human immunodeficiency virus infection
  • End-stage renal disease
  • Prior bariatric surgery
  • Prior organ transplantation
  • Transplant-related complications
  • Any use of tirzepatide before cohort entry

Treatment and study plan

Primary outcomes

  1. All-cause Mortality (Comparison 1)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

  2. All-cause Mortality (Comparison 2)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

  3. All-cause Mortality (Comparison 3)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

  4. All-cause Mortality (Comparison 4)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

  5. All-cause Mortality (Comparison 5)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

Secondary outcomes

  1. Inpatient (Comparison 1)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

  2. Inpatient (Comparison 2)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

  3. Inpatient (Comparison 3)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

  4. Inpatient (Comparison 4)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

  5. Inpatient (Comparison 5)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

  6. Pericardial Effusion (Comparison 1)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

  7. Pericardial Effusion (Comparison 2)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

  8. Pericardial Effusion (Comparison 3)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

  9. Pericardial Effusion (Comparison 4)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

  10. Pericardial Effusion (Comparison 5)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

  11. Pulmonary Embolism (Comparison 1)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

  12. Pulmonary Embolism (Comparison 2)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

  13. Pulmonary Embolism (Comparison 3)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

  14. Pulmonary Embolism (Comparison 4)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

  15. Pulmonary Embolism (Comparison 5)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

  16. Sepsis (Comparison 1)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

  17. Sepsis (Comparison 2)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

  18. Sepsis (Comparison 3)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

  19. Sepsis (Comparison 4)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

  20. Sepsis (Comparison 5)

    Time frame: From obesity-associated cancer diagnosis through 36 months

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Pre-Diagnosis GLP-1 Receptor Agonist Use and Post-Cancer Mortality in Adults With Obesity and Type 2 Diabetes: A Target Trial Emulation

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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