The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period

An observational study of Diabetes Mellitus, Type 2, run by Fourth People's Hospital of Shenyang.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Objective: The main target of this study was to research the early changes of retrobulbar and intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR). Read more about this study

Who is it for?: Ages 35 to 66 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Color doppler imaging
Type of treatment: Medical device
How many people: 66 participants
Where: No sites listed yet
Study dates: Feb 2016to May 2016
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 35 to 66 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The investigators selected 45 T2DM patients (25 males, 20 females) without microangiopathy (DR and DKD) as diabetes group and 38 healthy people (21 males, 17 females) as control group from the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 34 patients (19 males, 15 females) in the diabetes group and 32 healthy people (17 males, 15 females) can be researched in our study, all the participants were the Chinese Hans. All patients were provided a diet and exercise program by professional nutritionists.

Who may be able to join

The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ;
No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight;
Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and
Likely to have good compliance and able to visit our hospital for periodic assessments.

Who cannot join

T1DM, gestation and lactation;
Renal inadequacy,hypohepatia,and heart failure;
Intensive care with insulin treatment;
The patients combined with DR and hypertension (antihypertensive drugs were used);
Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery;
The patients combinated with DKD;
Patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter > 3 cm);
Cholesterol-lowering drugs can not control the blood-fat (TC > 250 mg/dl, HDL-C < 30 mg/dL, LDL-C > 170 mg/dl, TG > 200 mg/dl) adequately.

About this study

Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy people (control group) were recruited to research the early changes of renal function, retrobulbar and intrarenal hemodynamics, and then to research the correlation between them. The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C, and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.

Conditions: Diabetes Mellitus, Type 2
Being tested: Color doppler imaging
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.

Color doppler imagingDevice

Study groups in NCT02805543
Study group	Role	What they receive
diabetes group		34 T2DM patients without vascular complications as diabetes group Receives: Device: Color doppler imaging
control group		32 healthy people were recruited as control group Receives: Device: Color doppler imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients
RI(resistivity index)
Measured: 3 weeks
Retrobulbar RI in the bilateral Retrobulbar artery were evaluated using color doppler imaging (CDI) in 34 patients
RI(resistivity index),Retrobulbar artery［central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA)］
Measured: 3 weeks
The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients
RI(resistivity index)
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016May 2016

First posted20 Jun 2016 (estimated)
Study startFeb 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies 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-control
Time perspective: Retrospective
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02805543
Sponsor's protocol ID: 20160204
Other IDs: F11-262-9-25
Status last verified: Jun 2016
First submitted: 12 Jun 2016
Last updated: 20 Jun 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period
ClinicalTrials.gov ID: NCT02805543
Acronym / sponsor ID: 20160204
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Fourth People's Hospital of ShenyangUniversity, hospital or other
Study start: Feb 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 20 Jun 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.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
diabetes group	–	Device: Color doppler imaging34 T2DM patients without vascular complications as diabetes group
control group	–	Device: Color doppler imaging32 healthy people were recruited as control group

Who may qualify

Ages: 35 to 66 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The investigators selected 45 T2DM patients (25 males, 20 females) without microangiopathy (DR and DKD) as diabetes group and 38 healthy people (21 males, 17 females) as control group from the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 34 patients (19 males, 15 females) in the diabetes group and 32 healthy people (17 males, 15 females) can be researched in our study, all the participants were the Chinese Hans. All patients were provided a diet and exercise program by professional nutritionists.

Key inclusion criteria (4 listed)

The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ;
No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight;
Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and
Likely to have good compliance and able to visit our hospital for periodic assessments.

Key exclusion criteria (8 listed)

T1DM, gestation and lactation;
Renal inadequacy,hypohepatia,and heart failure;
Intensive care with insulin treatment;
The patients combined with DR and hypertension (antihypertensive drugs were used);
Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery;

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
Color doppler imaging	Device	control group, diabetes group

Primary outcome

Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients
Time frame: 3 weeks
RI(resistivity index)
Retrobulbar RI in the bilateral Retrobulbar artery were evaluated using color doppler imaging (CDI) in 34 patients
Time frame: 3 weeks
RI(resistivity index),Retrobulbar artery［central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA)］
The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients
Time frame: 3 weeks
RI(resistivity index)

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 20 Jun 2016.

Related trials for Diabetes Mellitus, Type 2

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
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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)
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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.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Fourth People's Hospital of Shenyang.

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 4 inclusion and 8 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 NCT02805543.

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 20 Jun 2016.