Carotid Body Function in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypoxia
• Interventions: Diagnostic Test: Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)

• Registration Number: NCT05237076
• Lead Sponsor: Leiden University Medical Center

Brief Summary

This trial will assess chemosensitivity differences of the carotid bodies in individuals with T2DM, compared to healthy controls. During baseline and hyperinsulinemia.

Detailed Description

During the COVID-19 pandemic patients with comorbidities such as hypertension, diabetes mellitus, obesity and pregnancy were overrepresented in the population that was admitted to the hospital. Morbidity and mortality due to SARS-COV-2 infection was higher in these patients compared to patients without these comorbidities. The higher incidence, morbidity and mortality is suggestive of an underlying mechanism that puts these patients more at risk. A proposed mechanism is the sympathetic overactivity that is associated with these conditions. Recently, it has become clear that the carotid bodies play an important role in sympathetic overactivity in these conditions. Dysfunction of this organ is associated with decreased chemosensitivity, disruption of insulin sensitivity, but is also associated with changes in neurohumoral control in response to infection. Whether carotid body dysfunction can explain the severity of SARS-COV-2 infection remains to be seen. The aim of this study is to find whether patients with type 2 diabetes have altered chemosensitivity and are in fact sympathetically overactive compared to healthy controls and during a hyperinsulinemic-euglycemic clamp. Findings could help explain why type 2 diabetes patients are more heavily affected by SARS-COV-2 and could identify potential targets for treatment in these patients.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Primary Completion: 2022-08-05
• Study Completion: 2023-02-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diabetes Type 2	Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)	Patients with DM Type 2 using Oral Diabetes Medications only.
Healthy controls	Hyperinsulemic-Euglycemic Clamp & Hypoxic Ventilatory Response (HVR)	Healthy controls without comorbidities.

Primary Outcome Measures

Name	Time	Method
Chemosensitivity of carotid bodies during baseline and euglycemic clamp	5 minutes	L/min/PaO2

Secondary Outcome Measures

Name	Time	Method
HRV during baseline and euglycemic clamp	30 min	HRV parameters

Trial Locations

Locations (1)

LUMC; 🇳🇱 Leiden, Zuid-Holland, Netherlands