Type 2 Diabetes MellitusNCT07847177
Nurse-Led Self-Management and Breathing Intervention in Type 2 Diabetes
A study testing Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program in people with Type 2 Diabetes Mellitus and Cardiovascular Autonomic Dysfunction, run by Aziza Ibrahim Mohamed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Autonomic Dysfunction
- What is being tested?
- Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2023to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiovascular Insult Associated With Autonomic Dysfunction in Type 2 Diabetes Mellitus and the Effect of a Structured Nurse-Led Home-Based Intervention: A Two-Phase Analytical Study
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.
Read the detailed description
Detailed Description
Type 2 diabetes mellitus is associated with cardiovascular autonomic dysfunction, which may contribute to impaired heart rate variability and increased cardiovascular risk. This study was conducted to evaluate cardiovascular autonomic function among individuals with type 2 diabetes mellitus and to determine the effectiveness of a structured nurse-led home-based intervention in improving autonomic function and cardiovascular indicators.
The interventional component used a randomized, two-arm, parallel-group design. A total of 80 participants with type 2 diabetes mellitus were randomly allocated in a 1:1 ratio to an intervention group (n=40) or a control group (n=40).
Participants assigned to the intervention group received a structured nurse-led home-based program consisting of regular walking, paced breathing exercises performed at approximately six breaths per minute, blood pressure and heart rate self-monitoring, individualized lifestyle and self-management counseling, behavioral reinforcement, and weekly telephone follow-up.
Participants assigned to the control group continued to receive their usual diabetes care without the structured nurse-led home-based intervention.
Cardiovascular autonomic function and blood pressure were assessed at baseline and during follow-up at Weeks 4, 8, and 12. The primary outcome was the root mean square of successive differences between normal heartbeats (rMSSD), an index of parasympathetic cardiac autonomic activity. Secondary outcomes included the low-frequency to high-frequency heart rate variability ratio (LF/HF) and systolic blood pressure.
- Being tested
- Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nurse-Led Home-Based Self-Management and Paced-Breathing ProgramBehavioural
A 12-week nurse-led home-based intervention designed to improve cardiovascular autonomic function and cardiovascular self-management among adults with type 2 diabetes mellitus. The intervention consisted of regular home-based walking, paced breathing exercises performed at approximately six breaths per minute, self-monitoring of blood pressure and heart rate, individualized education and lifestyle counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Home-Based Intervention | Experimental | Participants assigned to the intervention group received a 12-week structured nurse-led home-based self-management program. The program included regular home-based walking, paced breathing exercises at approximately six breaths per minute, blood pressure and heart rate self-monitoring, individualized lifestyle and diabetes self-management counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse. Receives: Behavioral: Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program |
| Usual Care Control | No intervention | Participants assigned to the control group continued to receive usual diabetes care and routine clinical follow-up. They did not receive the structured nurse-led home-based self-management and paced-breathing program during the 12-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Root Mean Square of Successive Differences (rMSSD) of Heart Rate Variability
rMSSD was used as a time-domain measure of heart rate variability reflecting cardiac parasympathetic autonomic activity. Higher rMSSD values indicate greater beat-to-beat heart rate variability and stronger parasympathetic modulation. Changes in rMSSD were evaluated across the study period to determine the effect of the nurse-led home-based intervention on cardiovascular autonomic function.
Measured: Time Frame: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (2)
Change in Systolic Blood Pressure
Systolic blood pressure was measured in millimeters of mercury (mmHg) using standardized blood pressure assessment procedures. Changes in systolic blood pressure were evaluated during the 12-week study period to assess the cardiovascular effect of the nurse-led home-based intervention.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Low-Frequency to High-Frequency Heart Rate Variability Ratio (LF/HF)
The LF/HF ratio was derived from frequency-domain heart rate variability analysis and was used to characterize the balance between low-frequency and high-frequency components of cardiac autonomic activity. Changes in the LF/HF ratio were assessed over the 12-week intervention period.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start12 Nov 2023
- Primary completion9 Apr 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with type 2 diabetes mellitus were randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving a 12-week structured nurse-led home-based self-management and paced-breathing program, or a control group receiving usual diabetes care. Outcomes were assessed at baseline and at Weeks 4, 8, and 12.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziza Ibrahim Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aziza Ibrahim Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847177
- Sponsor's protocol ID
- SOHAG-T2DM-HRV-23
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Insult Associated With Autonomic Dysfunction in Type 2 Diabetes Mellitus and the Effect of a Structured Nurse-Led Home-Based Intervention: A Two-Phase Analytical Study
- ClinicalTrials.gov ID
- NCT07847177
- Acronym / sponsor ID
- SOHAG-T2DM-HRV-23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aziza Ibrahim MohamedUniversity, hospital or other
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
Type 2 diabetes mellitus is associated with cardiovascular autonomic dysfunction, which may contribute to impaired heart rate variability and increased cardiovascular risk. This study was conducted to evaluate cardiovascular autonomic function among individuals with type 2 diabetes mellitus and to determine the effectiveness of a structured nurse-led home-based intervention in improving autonomic function and cardiovascular indicators.
The interventional component used a randomized, two-arm, parallel-group design. A total of 80 participants with type 2 diabetes mellitus were randomly allocated in a 1:1 ratio to an intervention group (n=40) or a control group (n=40).
Participants assigned to the intervention group received a structured nurse-led home-based program consisting of regular walking, paced breathing exercises performed at approximately six breaths per minute, blood pressure and heart rate self-monitoring, individualized lifestyle and self-management counseling, behavioral reinforcement, and weekly telephone follow-up.
Participants assigned to the control group continued to receive their usual diabetes care without the structured nurse-led home-based intervention.
Cardiovascular autonomic function and blood pressure were assessed at baseline and during follow-up at Weeks 4, 8, and 12. The primary outcome was the root mean square of successive differences between normal heartbeats (rMSSD), an index of parasympathetic cardiac autonomic activity. Secondary outcomes included the low-frequency to high-frequency heart rate variability ratio (LF/HF) and systolic blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with type 2 diabetes mellitus were randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving a 12-week structured nurse-led home-based self-management and paced-breathing program, or a control group receiving usual diabetes care. Outcomes were assessed at baseline and at Weeks 4, 8, and 12.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Home-Based Intervention | Experimental | Behavioral: Structured Nurse-Led Home-Based Self-Management and Paced-Breathing ProgramParticipants assigned to the intervention group received a 12-week structured nurse-led home-based self-management program. The program included regular home-based walking, paced breathing exercises at approximately six breaths per minute, blood pressure and heart rate self-monitoring, individualized lifestyle and diabetes self-management counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse. |
| Usual Care Control | No intervention | –Participants assigned to the control group continued to receive usual diabetes care and routine clinical follow-up. They did not receive the structured nurse-led home-based self-management and paced-breathing program during the 12-week study period. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Current or previous smoking.
- Ischemic heart disease.
- Cardiac arrhythmias.
- Chronic liver disease.
- Chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Nurse-Led Home-Based Self-Management and Paced-Breathing ProgramA 12-week nurse-led home-based intervention designed to improve cardiovascular autonomic function and cardiovascular self-management among adults with type 2 diabetes mellitus. The intervention consisted of regular home-based walking, paced breathing exercises performed at approximately six breaths per minute, self-monitoring of blood pressure and heart rate, individualized education and lifestyle counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse. | Behavioural | Nurse-Led Home-Based Intervention |
Primary outcome
Change in Root Mean Square of Successive Differences (rMSSD) of Heart Rate Variability
Time frame: Time Frame: Baseline, Week 4, Week 8, and Week 12
rMSSD was used as a time-domain measure of heart rate variability reflecting cardiac parasympathetic autonomic activity. Higher rMSSD values indicate greater beat-to-beat heart rate variability and stronger parasympathetic modulation. Changes in rMSSD were evaluated across the study period to determine the effect of the nurse-led home-based intervention on cardiovascular autonomic function.
2 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Low-Frequency to High-Frequency Heart Rate Variability Ratio (LF/HF)
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program in people with Type 2 Diabetes Mellitus and Cardiovascular Autonomic Dysfunction, run by Aziza Ibrahim Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Root Mean Square of Successive Differences (rMSSD) of Heart Rate Variability (time frame: Time Frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.