Lung Function in Patients With Early Type 2 Diabetes Mellitus

Liaoning University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulmonary Function; Type 2 Diabetes Mellitus

Treatments: Drug: Xuefuzhuyu Decoction & Calcium dobesilate; Drug: metformin; Drug: Xuefuzhuyu Decoction; Drug: Calcium Dobesilate; Drug: Mecobalamin Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03167918

20140721

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups

Calcium dobesilate

Experimental group

Description:

gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO

Treatment:

Drug: Mecobalamin Tablets

Drug: Calcium Dobesilate

Drug: metformin

Xuefuzhuyu Decoction

Experimental group

Description:

gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid，po

Treatment:

Drug: Mecobalamin Tablets

Drug: metformin

Drug: Xuefuzhuyu Decoction

Xuefuzhuyu Decoction &Calcium dobesilate

Experimental group

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)

Treatment:

Drug: Mecobalamin Tablets

Drug: metformin

Drug: Xuefuzhuyu Decoction & Calcium dobesilate