Type 2 DiabetesDMPACENCT04579406
Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
An observational study of Type 2 Diabetes and Neuropathy, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes, Neuropathy
- What is being tested?
- non-cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2020to 30 Jun 2023
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic patients with and without peripheral sensory neuropathy
Who may be able to join
- The main discharge diagnosis is T2DM；
- Age > 18 years old;
- No acute complications of diabetes
Who cannot join
- T1DM patients;
- EGFR < 60 ml/min/1.73 m or proteinuria (or both);
- Patients with history of acute cardiovascular events;
- Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
- anti-HIV patients;
- Patients with serious mental health problems;
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- Patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants;
- Patients with systemic inflammatory diseases, such as systemic lupus erythematosus;
- Patient are quitting smoking and severe obesity (BMI>40)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zheng Guo
Taiyuan, Shanxi, 030001
Zheng Guo, MB，PhD, +863513365790, guozheng713@yahoo.com
Weijun Liang, MSc, +863513365790, weijun_liang@126.com
About this study
Official title: Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.
Read the detailed description
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.
- Conditions
- Type 2 Diabetes, Neuropathy
- Being tested
- non-cardiac surgery
- Keywords
- Diabetes mellitus, adverse cardiovascular events, nerve degeneration, peripheral sensory nerves
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-cardiac surgeryProcedure or surgery
All the patients are undergoing non-cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| non-diabetic group | The non-diabetic patients undergoing non-cardiac surgery. Receives: Procedure: non-cardiac surgery | |
| Diabetic group | The diabetic patients without peripheral neuropathy undergoing non-cardiac surgery. Receives: Procedure: non-cardiac surgery | |
| Diabetic neuropathic group | The diabetic patients with peripheral neuropathy undergoing non-cardiac surgery. Receives: Procedure: non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse cardiovascular events
All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.
Measured: Perioperative period
Secondary outcomes (1)
NPY, CGRP, SP and TRPV1
The difference in the serum levels of NPY, CGRP, SP and TRPV1
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Zheng Guo, M.B., Ph.D., Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579406
- Sponsor's protocol ID
- ScondShanxiMU-1646
- Acronym
- DMPACE
- Status last verified
- Apr 2023
- First submitted
- 1 Oct 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes, if possible.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Changes in NPY, CGRP, SP and TRPV1 With Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04579406
- Acronym / sponsor ID
- DMPACE / ScondShanxiMU-1646
- Conditions
- Type 2 Diabetes, Neuropathy
- Keywords
- Diabetes mellitus, adverse cardiovascular events, nerve degeneration, peripheral sensory nerves
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Oct 2020 (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.
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.
Detailed description
The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery. Diabetes mellitus and peripheral sensory nerve degeneration will be diagnosed via clinical evaluation. Serum levels of constituent neuropeptides, including neuropeptide Y (NPY), calcitonin and substance P (SP) and calcitonin gene related peptide (CGRP), and transient receptor potential vanilloid 1 (TRPV1), a molecular nociceptor in peripheral sensory nerves will be quantitatively evaluated. The clinical and the biochemical consequence will be compared between the cohorts of diabetic and non-diabetic patients. The differences and the correlations will be analyzed. The results of the study may reveal whether or not the perioperative adverse cardiovascular events in diabetic patients are correlated with degeneration of peripheral sensory nerves and the alterations in the neuropeptides and TRPV1 are potentially applicable for evaluation of the risk of cardiovascular events in perioperative period in diabetic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-diabetic group | – | Procedure: non-cardiac surgeryThe non-diabetic patients undergoing non-cardiac surgery. |
| Diabetic group | – | Procedure: non-cardiac surgeryThe diabetic patients without peripheral neuropathy undergoing non-cardiac surgery. |
| Diabetic neuropathic group | – | Procedure: non-cardiac surgeryThe diabetic patients with peripheral neuropathy undergoing non-cardiac surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients with and without peripheral sensory neuropathy
Key inclusion criteria (3 listed)
- The main discharge diagnosis is T2DM；
- Age > 18 years old;
- No acute complications of diabetes
Key exclusion criteria (9 listed)
- T1DM patients;
- EGFR < 60 ml/min/1.73 m or proteinuria (or both);
- Patients with history of acute cardiovascular events;
- Familial hypercholesterolemia or other hereditary lipid metabolism diseases;
- anti-HIV patients;
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 |
|---|---|---|
| non-cardiac surgeryAll the patients are undergoing non-cardiac surgery. | Procedure or surgery | Diabetic group, Diabetic neuropathic group, non-diabetic group |
Primary outcome
adverse cardiovascular events
Time frame: Perioperative period
All the pre-, intra- and post-operative adverse cardiovascular events in the patients will be taken into account.
1 secondary outcome
NPY, CGRP, SP and TRPV1
Time frame: Perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided. Yes, if possible.
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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.
Zheng Guo, M.B., Ph.D. study director
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Neuropathy, run by Second Hospital of Shanxi Medical University at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Guo, M.B., Ph.D. (+863513365790, guozheng713@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse cardiovascular events (time frame: Perioperative period). 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 12 Apr 2023.