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Completed
NCT07847177
Nurse-Led Self-Management and Breathing Intervention in Type 2 Diabetes
Conditions: Type 2 Diabetes Mellitus, Cardiovascular Autonomic Dysfunction
Sex: Male
Ages: 35 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Aziza Ibrahim Mohamed
Location: Mansoura University Hospitals Al Mansurah Dakahlia Governorate
Summary
Brief Summary
This study evaluated the effect of a structured nurse-led home-based self-management and paced-breathing intervention on cardiovascular autonomic function and blood pressure among adults with type 2 diabetes mellitus. Participants with type 2 diabetes were randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention included a structured home-based walking program, paced breathing at six breaths per minute, blood pressure and heart rate self-monitoring, lifestyle counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse. Outcomes were assessed at baseline and at Weeks 4, 8, and 12.
Eligibility Criteria
Inclusion Criteria:
Male participants aged 35-55 years.
Documented diagnosis of type 2 diabetes mellitus for at least 1 year.
Receiving stable pharmacological treatment for at least 3 months before enrollment.
Clinically stable at the time of assessment.
Willing to participate and provide written informed consent.
Exclusion Criteria:
Current or previous smoking.
Ischemic heart disease.
Cardiac arrhythmias.
Chronic liver disease.
Chronic kidney disease.
Neurological disorders unrelated to diabetes.
Use of medications known to substantially influence autonomic nervous system function.
Source: ClinicalTrials.gov (NCT07847177). StuddyBuddy aggregates publicly available trial information.
