NCT03167918

Lung Function in Patients With Early Type 2 Diabetes Mellitus

Liaoning University of Traditional Chinese Medicine

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Liaoning University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Calcium Dobesilate	gave each patient 0.5 g bid，
DRUG	Xuefuzhuyu Decoction	gave each patient100 ml bid，po
DRUG	Xuefuzhuyu Decoction & Calcium dobesilate	gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po
DRUG	metformin	gave each patient 1000 mg, bid, PO
DRUG	Mecobalamin Tablets	gave each patient 0.5 mg bid, PO

Timeline

• Start date: 2014-07-21
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2017-05-30
• Last updated: 2017-05-30