Lung Function in Patients With Early Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus, Pulmonary Function
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Calcium Dobesilate
Xuefuzhuyu Decoction
Xuefuzhuyu Decoction & Calcium dobesilate
metformin
Mecobalamin Tablets
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- , 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Calcium dobesilate
Xuefuzhuyu Decoction
Xuefuzhuyu Decoction &Calcium dobesilate
Arm Description
gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO
gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid,po
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)
Outcomes
Primary Outcome Measures
Changes in pulmonary function parameters
The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03167918
First Posted
May 15, 2017
Last Updated
May 24, 2017
Sponsor
Liaoning University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03167918
Brief Title
Lung Function in Patients With Early Type 2 Diabetes Mellitus
Official Title
Liaoning University of Traditional Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 21, 2014 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaoning University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Pulmonary Function
Keywords
calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium dobesilate
Arm Type
Experimental
Arm Description
gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO
Arm Title
Xuefuzhuyu Decoction
Arm Type
Experimental
Arm Description
gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid,po
Arm Title
Xuefuzhuyu Decoction &Calcium dobesilate
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Calcium Dobesilate
Intervention Description
gave each patient 0.5 g bid,
Intervention Type
Drug
Intervention Name(s)
Xuefuzhuyu Decoction
Intervention Description
gave each patient100 ml bid,po
Intervention Type
Drug
Intervention Name(s)
Xuefuzhuyu Decoction & Calcium dobesilate
Intervention Description
gave each patient Calcium dobesilate 0.5 g bid,po and Xuefuzhuyu Decoction 100 ml bid,po
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
gave each patient 1000 mg, bid, PO
Intervention Type
Drug
Intervention Name(s)
Mecobalamin Tablets
Intervention Description
gave each patient 0.5 mg bid, PO
Primary Outcome Measure Information:
Title
Changes in pulmonary function parameters
Description
The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,
Description
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
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat
Description
The quartus endpoints were the changes from baseline to week 26 in Systolic blood pressure,Diastolic blood pressure, and blood-fat
Time Frame
26 weeks
Title
Changes in retrobulbar hemodynamics (RI)
Description
The fifth endpoints were the changes from baseline to week 26 in retrobulbar hemodynamics (RI) in the bilateral central retinal artery,posterior ciliary artery, endarteria ophthalmica.
Time Frame
26 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-lin Jiang
Organizational Affiliation
Liaoning University of Traditional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Lung Function in Patients With Early Type 2 Diabetes Mellitus
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