Type 2 Diabetes MellitusPhase 2/3NCT03167918
Lung Function in Patients With Early Type 2 Diabetes Mellitus
A Phase 2/3 study testing Calcium Dobesilate, Xuefuzhuyu Decoction and Xuefuzhuyu Decoction & Calcium dobesilate in people with Type 2 Diabetes Mellitus and Pulmonary Function, run by Liaoning University of Traditional Chinese Medicine.
Trial summary
To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes mellitus Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Pulmonary Function
- What is being tested?
- Calcium Dobesilate, Xuefuzhuyu Decoction and Xuefuzhuyu Decoction & Calcium dobesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2014to 1 May 2017
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients who were diagnosed with type 2 diabetes mellitus according to the guidelines of the American Diabetes Association ;
- had no history of smoking, pulmonary disease, cold, or pulmonary infection within a two-week period;
- were not diagnosed with hepatopathy, nephropathy, hyperuricemia, or gastrointestinal disease;
- were likely to have good compliance and were able to visit our hospital for periodic assessments.
Who cannot join
- , type 1 diabetes, pregnant women;
- there are important organ dysfunction;
- the need to control blood glucose after insulin injection (poor drug control);
- the life of patients with irregular or serious addiction (alcoholism),
- poor compliance and compliance;
- the experiment of drug intolerance (severe allergic reaction 6);
- hypertension and hyperuricemia;
- and nearly two weeks colds, pneumonia and other respiratory diseases.
About this study
Official title: Liaoning University of Traditional Chinese Medicine
To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes mellitus
Read the detailed description
Test group and treatment: the patients with type 2 diabetes mellitus were randomly divided into calcium dobesilate group, Xuefuzhuyu Decoction group and combination group. All participants were given hypoglycemic, metformin (1000 mg, bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. Calcium dobesilate group were given hypoglycemic, metformin (500 mg tid, PO), to improve the circular Calcium Dobesilate Capsules (0.5 g bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. Xuefuzhuyu Decoction group was given hypoglycemic, metformin (500 mg tid, PO), to improve the circular Xuefuzhuyu Decoction (100 ml bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. The combined treatment group was given metformin hypoglycemic (500 mg tid, PO), Calcium Dobesilate Capsules, improve circulation (0.5 g bid, PO) + Xuefuzhuyu Decoction (100 ml, bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO). Before treatment, three groups of patients with blood glucose, oxidation related indicators, retrobulbar hemodynamics and pulmonary function were recorded.
Detection: continuous treatment were observed before and after treatment of the three groups of patients after 24 weeks of fasting blood glucose (FBG), 2 hour postprandial blood glucose (2hPBG), body mass index (BMI), peripheral blood glycated hemoglobin (HbA1c) and related indexes of oxidation, superoxide dismutase (SOD), glutathione peroxidase, Gu Guang (GSH-Px), reactive oxygen species (ROS) activity, malondialdehyde (MDA) concentration and pulmonary function, vital capacity (VC%), forced vital capacity (FVC%), one second forced expiratory flow (FEV1%), peak expiratory flow (PEF%), maximal voluntary ventilation (MVV%), total lung capacity (TCL%) and a second rate (FEV1/FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), lung volume diffusion capacity of carbon monoxide (DLCO/VA%) changes of the central retinal artery (CRA) and posterior ciliary artery (PCA), eye movement The changes of blood flow velocity and resistance index (RI) of the pulse (AO) systolic and diastolic blood flow were recorded.
- Conditions
- Type 2 Diabetes Mellitus, Pulmonary Function
- Being tested
- Calcium Dobesilate, Xuefuzhuyu Decoction, Xuefuzhuyu Decoction & Calcium dobesilate, metformin, Mecobalamin Tablets
- Keywords
- calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function
- 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.
Calcium DobesilateDrug
gave each patient 0.5 g bid，
Xuefuzhuyu DecoctionDrug
gave each patient100 ml bid，po
Xuefuzhuyu Decoction & Calcium dobesilateDrug
gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po
metforminDrug
gave each patient 1000 mg, bid, PO
Mecobalamin TabletsDrug
gave each patient 0.5 mg bid, PO
| Study group | Role | What they receive |
|---|---|---|
| Calcium dobesilate | Experimental | gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO Receives: Drug: Calcium Dobesilate; Drug: metformin; Drug: Mecobalamin Tablets |
| Xuefuzhuyu Decoction | Experimental | gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid，po Receives: Drug: Xuefuzhuyu Decoction; Drug: metformin; Drug: Mecobalamin Tablets |
| Xuefuzhuyu Decoction &Calcium dobesilate | Experimental | gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate (0.5 g bid, PO)\& Xuefuzhuyu Decoction（100 ml bid，po) Receives: Drug: Xuefuzhuyu Decoction & Calcium dobesilate; Drug: metformin; Drug: Mecobalamin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulmonary function parameters
The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment
Measured: 26 weeks
Secondary outcomes (1)
Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,
The secondary endpoints were changes from baseline to week 26 in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,. The tertiary endpoints were the changes from baseline to week 26 in blood-fat
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start21 Jul 2014
- Primary completion1 Apr 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolin Jiang, Liaoning University of Traditional Chinese Medicine
- Investigators
- Xiao-lin Jiang, Principal investigator, Liaoning University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167918
- Sponsor's protocol ID
- 20140721
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liaoning University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT03167918
- Acronym / sponsor ID
- 20140721
- Conditions
- Type 2 Diabetes Mellitus, Pulmonary Function
- Keywords
- calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 30 May 2017 (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.
To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes mellitus
Detailed description
Test group and treatment: the patients with type 2 diabetes mellitus were randomly divided into calcium dobesilate group, Xuefuzhuyu Decoction group and combination group. All participants were given hypoglycemic, metformin (1000 mg, bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. Calcium dobesilate group were given hypoglycemic, metformin (500 mg tid, PO), to improve the circular Calcium Dobesilate Capsules (0.5 g bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. Xuefuzhuyu Decoction group was given hypoglycemic, metformin (500 mg tid, PO), to improve the circular Xuefuzhuyu Decoction (100 ml bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO): treatment. The combined treatment group was given metformin hypoglycemic (500 mg tid, PO), Calcium Dobesilate Capsules, improve circulation (0.5 g bid, PO) + Xuefuzhuyu Decoction (100 ml, bid, PO), Mecobalamin Tablets, nerve nutrition (0.5 mg bid, PO). Before treatment, three groups of patients with blood glucose, oxidation related indicators, retrobulbar hemodynamics and pulmonary function were recorded.
Detection: continuous treatment were observed before and after treatment of the three groups of patients after 24 weeks of fasting blood glucose (FBG), 2 hour postprandial blood glucose (2hPBG), body mass index (BMI), peripheral blood glycated hemoglobin (HbA1c) and related indexes of oxidation, superoxide dismutase (SOD), glutathione peroxidase, Gu Guang (GSH-Px), reactive oxygen species (ROS) activity, malondialdehyde (MDA) concentration and pulmonary function, vital capacity (VC%), forced vital capacity (FVC%), one second forced expiratory flow (FEV1%), peak expiratory flow (PEF%), maximal voluntary ventilation (MVV%), total lung capacity (TCL%) and a second rate (FEV1/FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), lung volume diffusion capacity of carbon monoxide (DLCO/VA%) changes of the central retinal artery (CRA) and posterior ciliary artery (PCA), eye movement The changes of blood flow velocity and resistance index (RI) of the pulse (AO) systolic and diastolic blood flow were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium dobesilate | Experimental | Drug: Calcium Dobesilate, Drug: metformin, Drug: Mecobalamin Tabletsgave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO |
| Xuefuzhuyu Decoction | Experimental | Drug: Xuefuzhuyu Decoction, Drug: metformin, Drug: Mecobalamin Tabletsgave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid，po |
| Xuefuzhuyu Decoction &Calcium dobesilate | Experimental | Drug: Xuefuzhuyu Decoction & Calcium dobesilate, Drug: metformin, Drug: Mecobalamin Tabletsgave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate (0.5 g bid, PO)\& Xuefuzhuyu Decoction（100 ml bid，po) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients who were diagnosed with type 2 diabetes mellitus according to the guidelines of the American Diabetes Association ;
- had no history of smoking, pulmonary disease, cold, or pulmonary infection within a two-week period;
- were not diagnosed with hepatopathy, nephropathy, hyperuricemia, or gastrointestinal disease;
- were likely to have good compliance and were able to visit our hospital for periodic assessments.
Key exclusion criteria (8 listed)
- , type 1 diabetes, pregnant women;
- there are important organ dysfunction;
- the need to control blood glucose after insulin injection (poor drug control);
- the life of patients with irregular or serious addiction (alcoholism),
- poor compliance and compliance;
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 |
|---|---|---|
| Calcium Dobesilategave each patient 0.5 g bid， | Drug | Calcium dobesilate |
| Xuefuzhuyu Decoctiongave each patient100 ml bid，po | Drug | Xuefuzhuyu Decoction |
| Xuefuzhuyu Decoction & Calcium dobesilategave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po | Drug | Xuefuzhuyu Decoction &Calcium dobesilate |
| metformingave each patient 1000 mg, bid, PO | Drug | Calcium dobesilate, Xuefuzhuyu Decoction, Xuefuzhuyu Decoction &Calcium dobesilate |
| Mecobalamin Tabletsgave each patient 0.5 mg bid, PO | Drug | Calcium dobesilate, Xuefuzhuyu Decoction, Xuefuzhuyu Decoction &Calcium dobesilate |
Primary outcome
Changes in pulmonary function parameters
Time frame: 26 weeks
The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment
1 secondary outcome
Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,
Time frame: 26 weeks
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 30 May 2017.
- Individual participant dataSharing planned: No
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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.
Xiao-lin Jiang principal investigator
Liaoning University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcium Dobesilate, Xuefuzhuyu Decoction and Xuefuzhuyu Decoction & Calcium dobesilate in people with Type 2 Diabetes Mellitus and Pulmonary Function, run by Liaoning University of Traditional Chinese Medicine.
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 30 May 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in pulmonary function parameters (time frame: 26 weeks). 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 30 May 2017.