Type2 Diabetes MellitusNCT02996539
Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
An observational study of Type2 Diabetes Mellitus, run by Shi wei, MM at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Clinical examination and laboratory measurements
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Apr 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 392 patients of T2DM consecutively recruited from February 2013 to April 2015 in the inpatient department of Kunming First People's Hospital.The Institutional Review Board of Kunming First People's Hospital approved the study protocol. Adult patients with T2DM who had consecutively undergone 24-hour Holter monitoring for HRV analysis were included.
Who may be able to join
- Clinical diagnosis of T2DM
- Adult patients has had consecutively undergone 24-hour Holter monitoring for heart rate variability analysis
Who cannot join
- Patients with acute complications of DM including diabetic ketoacidosis, hyperosmolar coma
- Foot ulcer
- Severe acute or chronic infection
- Chronic liver disease
- Dialysis or renal transplantation
- The presence of any serious concomitant disease affecting life expectancy were not eligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Internal medicine department, Kunming First People's Hospital
Kunming, Yunnan, 650000
About this study
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).
Read the detailed description
present study investigated an association between HRV parameters and DKD in Chinese T2DM patients, specifically through time and frequency domain analyses of HRV and UACR or eGFR
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Clinical examination and laboratory measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination and laboratory measurementsOther
Also called Physical examination and blood urine samples collection
Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | With Clinical examination and laboratory measurements Receives: Other: Clinical examination and laboratory measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between HRV and renal function (eGFR and UACR)
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 molecular weight in micromole, volume in litre;urine volume per minute in milliliter per minute; body surface area in square meter) based on SCr levels. Albuminuria was defined using UACR of a single early-morning urine measurement.For all Participants, 132 patients had albuminuria and 50 patients with eGFR < 60 mL/min/1.73 m^2
Measured: 1week
Secondary outcomes (1)
Clinical characteristics of patients
Clinical examination and laboratory measurements Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. A trained examiner measured the height (in meters) and body weight (in kilograms) of the patients. Body mass index (BMI) in kg/m^2, weight in kilograms, height in meters. Hypertension was defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, or both, or if the patient was already taking anti-hypertensive drugs. Blood and urine samples were analyzed at the medical examination center of Kunming First People's Hospital.
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 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
- Observational
- Observational model
- Case only
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shi wei, MM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi wei, MM, First People's Hospital of Kunming
- Investigators
- Xiaolei Chen, MM, Study chair, Kunming first people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996539
- Sponsor's protocol ID
- FirstPHKunming
- Status last verified
- Dec 2016
- First submitted
- 24 Nov 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The basic records of patients
Publications
Tuttle KR, Bakris GL, Bilous RW, Chiang JL, de Boer IH, Goldstein-Fuchs J, Hirsch IB, Kalantar-Zadeh K, Narva AS, Navaneethan SD, Neumiller JJ, Patel UD, Ratner RE, Whaley-Connell AT, Molitch ME. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care. 2014 Oct;37(10):2864-83. doi: 10.2337/dc14-1296.
PubMed 25249672
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT02996539
- Acronym / sponsor ID
- FirstPHKunming
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Shi wei, MMUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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.
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).
Detailed description
present study investigated an association between HRV parameters and DKD in Chinese T2DM patients, specifically through time and frequency domain analyses of HRV and UACR or eGFR
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Other: Clinical examination and laboratory measurementsWith Clinical examination and laboratory measurements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 392 patients of T2DM consecutively recruited from February 2013 to April 2015 in the inpatient department of Kunming First People's Hospital.The Institutional Review Board of Kunming First People's Hospital approved the study protocol. Adult patients with T2DM who had consecutively undergone 24-hour Holter monitoring for HRV analysis were included.
Key inclusion criteria (2 listed)
- Clinical diagnosis of T2DM
- Adult patients has had consecutively undergone 24-hour Holter monitoring for heart rate variability analysis
Key exclusion criteria (6 listed)
- Patients with acute complications of DM including diabetic ketoacidosis, hyperosmolar coma
- Foot ulcer
- Severe acute or chronic infection
- Chronic liver disease
- Dialysis or renal transplantation
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 |
|---|---|---|
| Clinical examination and laboratory measurementsAlso: Physical examination and blood urine samples collectionSubjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively. | Other | Type 2 diabetes |
Primary outcome
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 molecular weight in micromole, volume in litre;urine volume per minute in milliliter per minute; body surface area in square meter) based on SCr levels. Albuminuria was defined using UACR of a single early-morning urine measurement.For all Participants, 132 patients had albuminuria and 50 patients with eGFR < 60 mL/min/1.73 m^2
1 secondary outcome
Clinical characteristics of patients
Time frame: 1week
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 19 Dec 2016.
- Background: PubMed 25249672Tuttle KR, Bakris GL, Bilous RW, Chiang JL, de Boer IH, Goldstein-Fuchs J, Hirsch IB, Kalantar-Zadeh K, Narva AS, Navaneethan SD, Neumiller JJ, Patel UD, Ratner RE, Whaley-Connell AT, Molitch ME. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care. 2014 Oct;37(10):2864-83. doi: 10.2337/dc14-1296.
- test linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The basic records of patients
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Xiaolei Chen, MM study chair
Kunming first people's hospital
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 Type2 Diabetes Mellitus, run by Shi wei, MM 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 2 inclusion and 6 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 19 Dec 2016. 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?
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?
Association between HRV and renal function (eGFR and UACR) (time frame: 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996539, which also lists 1 linked publication.
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 19 Dec 2016.