Clinical trial NCT03167918: Lung Function in Patients With Early Type 2 Diabetes Mellitus
Official title: Liaoning University of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Pulmonary Function
Keywords: calcium dobesilate
Xuefuzhuyu Decoction
pulmonary function
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. patients who were diagnosed with type 2 diabetes mellitus according to the guidelines of the American Diabetes Association ;
2. had no history of smoking, pulmonary disease, cold, or pulmonary infection within a two-week period;
3. were not diagnosed with hepatopathy, nephropathy, hyperuricemia, or gastrointestinal disease;
4. were likely to have good compliance and were able to visit our hospital for periodic assessments.

Exclusion Criteria:

1. , type 1 diabetes, pregnant women;
2. there are important organ dysfunction;
3. the need to control blood glucose after insulin injection (poor drug control);
4. the life of patients with irregular or serious addiction (alcoholism),
5. poor compliance and compliance;
6. the experiment of drug intolerance (severe allergic reaction 6);
7. hypertension and hyperuricemia;
8. and nearly two weeks colds, pneumonia and other respiratory diseases.

Primary outcomes:
measure: Changes in pulmonary function parameters
timeFrame: 26 weeks
Secondary outcomes:
measure: Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,
timeFrame: 26 weeks
Other outcomes:
measure: Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat
timeFrame: 26 weeks
measure: Changes in retrobulbar hemodynamics (RI)
timeFrame: 26 weeks
Locations:
Study officials:
affiliation: Liaoning University of Traditional Chinese Medicine
name: Xiao-lin Jiang
role: PRINCIPAL_INVESTIGATOR
References: