Lung Function in Patients With Early Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Pulmonary Function; Type 2 Diabetes Mellitus
• Interventions: Drug: Calcium Dobesilate; Drug: Xuefuzhuyu Decoction & Calcium dobesilate; Drug: Xuefuzhuyu Decoction; Drug: metformin; Drug: Mecobalamin Tablets

• Registration Number: NCT03167918
• Lead Sponsor: Liaoning University of Traditional Chinese Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-07-21
• Primary Completion: 2017-04-01
• Status Verified: 2017-05
• Study Completion: 2017-05-01
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium dobesilate	Mecobalamin Tablets	gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO
Calcium dobesilate	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	Mecobalamin Tablets	gave 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	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)
Xuefuzhuyu Decoction	Xuefuzhuyu Decoction	gave 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	Mecobalamin Tablets	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)
Calcium dobesilate	metformin	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	metformin	gave 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	metformin	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)

Primary Outcome Measures

Name	Time	Method
Changes in pulmonary function parameters	26 weeks	The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment

Secondary Outcome Measures

Name	Time	Method
Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,	26 weeks	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