Lung Function in Patients With Early Type 2 Diabetes Mellitus

NCT ID: NCT03167918

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-21
• Study Completion Date: 2017-05-01

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.

Conditions

Type 2 Diabetes Mellitus; Pulmonary Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Xuefuzhuyu Decoction &Calcium dobesilate

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)

Group Type: EXPERIMENTAL

Xuefuzhuyu Decoction & Calcium dobesilate

Intervention Type: DRUG

gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po

metformin

Intervention Type: DRUG

gave each patient 1000 mg, bid, PO

Mecobalamin Tablets

Intervention Type: DRUG

gave each patient 0.5 mg bid, PO

Calcium dobesilate

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

Group Type: EXPERIMENTAL

Calcium Dobesilate

Intervention Type: DRUG

gave each patient 0.5 g bid，

metformin

Intervention Type: DRUG

gave each patient 1000 mg, bid, PO

Mecobalamin Tablets

Intervention Type: DRUG

gave each patient 0.5 mg bid, PO

Xuefuzhuyu Decoction

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

Group Type: EXPERIMENTAL

Xuefuzhuyu Decoction

Intervention Type: DRUG

gave each patient100 ml bid，po

metformin

Intervention Type: DRUG

gave each patient 1000 mg, bid, PO

Mecobalamin Tablets

Intervention Type: DRUG

gave each patient 0.5 mg bid, PO

Interventions

Calcium Dobesilate

gave each patient 0.5 g bid，

Intervention Type: DRUG

Xuefuzhuyu Decoction

gave each patient100 ml bid，po

Intervention Type: DRUG

Xuefuzhuyu Decoction & Calcium dobesilate

gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po

Intervention Type: DRUG

metformin

gave each patient 1000 mg, bid, PO

Intervention Type: DRUG

Mecobalamin Tablets

gave each patient 0.5 mg bid, PO

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaolin Jiang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-lin Jiang

Role: PRINCIPAL_INVESTIGATOR

Liaoning University of Traditional Chinese Medicine

Other Identifiers

20140721

Identifier Type: -

Identifier Source: org_study_id