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Investigation of diagnose and therapy of cardiovascular autonomic neuropathy in patients with diabetes and prediabetes

Investigation of diagnose and therapy of cardiovascular autonomic neuropathy in patients with diabetes and prediabetes

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052971
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes cardiovascular autonomic neuropathy

Interventions

case series:No

Sponsors

Ningbo Huamei Hospital,University of Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients from Department of Endocrinology and Department of Cardiology, Ningbo Huamei Hospital, University of Chinese Academy of Sciences; 2. Diagnosis of type 2 diabetes:Three more symptoms and one less symptom + fasting blood glucose >= 7.0 or random blood glucose >= 11.1 or 75g OGTT 2h >= 11.1 mmol/L (OGTT is performed when fasting blood glucose >= 6.1 or random blood glucose >= 7.8); If there are no symptoms of three more and one less, it needs to be re-tested for confirmation on another day; Excluding stress, it can be combined with glycosylated hemoglobin >= 6.5%; 3. Or diagnosed with prediabetes: fasting blood glucose >= 6.1mmol/L, = 7.8, <11.1mmol/L; 4. Understand and sign the informed consent form before proceeding with any steps related to this study; 5. Agree not to participate in other studies, and try not to accept other drugs or clinical interventions that affect cardiovascular autonomic function during the study period, and make records when necessary.

Exclusion criteria

Exclusion criteria: 1. Cardiovascular organic diseases: dilated cardiomyopathy, rheumatic heart disease, pulmonary hypertension, pulmonary heart disease, restrictive heart disease and other definite cardiovascular structural and functional abnormalities, but atherosclerotic cardiovascular disease (ASCVD) not excluded; 2. Other diseases that may affect the cardiovascular autonomic nervous system: pheochromocytoma, hyperthyroidism, hypothyroidism, mental diseases, etc.; 3. Pregnant women, lactating women or those who use estrogen contraception, who do not use effective contraception, and who have the intention of becoming pregnant within 1 year; 4. Severe liver and kidney disease (GFR < 30 mL/min/1.73m2) and other serious diseases that need to be excluded by the investigator's judgment; 5. Those with alcoholism or intravenous drug addiction within 3 months; 6. Those who are positive for infectious diseases, including HIV, HBV, HCV, and syphilis; 7. Patients with a history of mental illness; 8. Those who have participated in other clinical investigators in the past 3 months and cannot comply with the research protocol; 9. Any other conditions that the investigator judges that the patient is not suitable for inclusion in the clinical study.

Design outcomes

Primary

MeasureTime frame
heart rate variability;blood pressure variability;

Countries

China

Contacts

Public ContactYe Honghua

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

lindayenbzjch@163.com+86 13505743664

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026