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Completed

NCT Number: NCT03167918

Lung Function in Patients With Early Type 2 Diabetes Mellitus

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Calcium Dobesilate

Drug

gave each patient 0.5 g bid,

Xuefuzhuyu Decoction

Drug

gave each patient100 ml bid,po

Xuefuzhuyu Decoction & Calcium dobesilate

Drug

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

metformin

Drug

gave each patient 1000 mg, bid, PO

Mecobalamin Tablets

Drug

gave each patient 0.5 mg bid, PO

Primary outcomes

  1. Changes in pulmonary function parameters

    Time frame: 26 weeks

    The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment

Secondary outcomes

  1. Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,

    Time frame: 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

Other outcomes

  1. Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat

    Time frame: 26 weeks

    The quartus endpoints were the changes from baseline to week 26 in Systolic blood pressure,Diastolic blood pressure, and blood-fat

  2. Changes in retrobulbar hemodynamics (RI)

    Time frame: 26 weeks

    The fifth endpoints were the changes from baseline to week 26 in retrobulbar hemodynamics (RI) in the bilateral central retinal artery,posterior ciliary artery, endarteria ophthalmica.

Sponsors and collaborators

Lead sponsor

Liaoning University of Traditional Chinese Medicine

Other

Registry information

Official study title

Liaoning University of Traditional Chinese Medicine

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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