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NCT02996539
Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
trial testing Clinical examination and laboratory measurements in Type2 Diabetes Mellitus in 392 participants. Completed in 1 April 2015.
1 April 2015
Quick facts
| Lead sponsor | Shi wei, MM |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 392 |
| Start date | 1 February 2013 |
| Primary completion | 1 April 2015 |
| Estimated completion | 1 April 2015 |
| Sites | 1 location across China |
Drugs / interventions tested
- Clinical examination and laboratory measurements
Conditions studied
- Type2 Diabetes Mellitus — all drugs for Type2 Diabetes Mellitus →
Sponsor
Shi wei, MM
Who can join
Adults 18 to 80, any sex, with Type2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Association between HRV and renal function (eGFR and UACR)
Time frame: 1week
Assessment of HRV HRV measurement based on 24-hour ambulatory ECG monitoring was obtained from all patients using a 3- channel digital Holter recorder (CB-2302-A, Wuxi, Jiangsu, China). Assessment of DKD DKD was defined as the presence of albuminuria (UACR ≥ 30 mg/g,urine albumin in milligram,creatinine in gram) or eGFR \< 60 mL/min/1.73 m\^2 (creatinine concentration in umol/l,creatinine molecula
Sponsor's own description
Several studies have investigated an association between cardiac autonomic neuropathy (CAN) and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians and were limited to a small number of patients with type 1 diabetes mellitus, or had used a conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is consistent data showing that Asian diabetic populations, including the Chinese, have a higher risk of renal complications than Caucasians do. The present study investigated an association between heart rate variability (HRV) parameters and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients, specifically through time and frequency domain analyses of HRV and urine albumin creatinine ratio (UACR) or estimated glomerular filtration rate (eGFR).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Heart Rate Variability and Chronic Kidney Disease in Patients with Type 2 Diabetes.
Shi W, Zhang J, Chen D, Chen X, et al · · 2022 · cited 3× · PMID 35619730 · DOI 10.1155/2022/2475750
Verify or expand the search:
- PubMed search for NCT02996539
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT03647306 — Behavioral Chronotype: Impact on Sleep and Metabolism · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02996539 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shi wei, MM
- Last refreshed: 14 December 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02996539.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing