search
Back to results

Lung Function in Patients With Early Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus, Pulmonary Function

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Calcium Dobesilate
Xuefuzhuyu Decoction
Xuefuzhuyu Decoction & Calcium dobesilate
metformin
Mecobalamin Tablets
Sponsored by
Liaoning University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Calcium dobesilate

    Xuefuzhuyu Decoction

    Xuefuzhuyu Decoction &Calcium dobesilate

    Arm Description

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

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

    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)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 15, 2017
    Last Updated
    May 24, 2017
    Sponsor
    Liaoning University of Traditional Chinese Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03167918
    Brief Title
    Lung Function in Patients With Early Type 2 Diabetes Mellitus
    Official Title
    Liaoning University of Traditional Chinese Medicine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 21, 2014 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Liaoning University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus, Pulmonary Function
    Keywords
    calcium dobesilate, Xuefuzhuyu Decoction, pulmonary function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Calcium dobesilate
    Arm Type
    Experimental
    Arm Description
    gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO
    Arm Title
    Xuefuzhuyu Decoction
    Arm Type
    Experimental
    Arm Description
    gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid,po
    Arm Title
    Xuefuzhuyu Decoction &Calcium dobesilate
    Arm Type
    Experimental
    Arm 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)
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium Dobesilate
    Intervention Description
    gave each patient 0.5 g bid,
    Intervention Type
    Drug
    Intervention Name(s)
    Xuefuzhuyu Decoction
    Intervention Description
    gave each patient100 ml bid,po
    Intervention Type
    Drug
    Intervention Name(s)
    Xuefuzhuyu Decoction & Calcium dobesilate
    Intervention Description
    gave each patient Calcium dobesilate 0.5 g bid,po and Xuefuzhuyu Decoction 100 ml bid,po
    Intervention Type
    Drug
    Intervention Name(s)
    metformin
    Intervention Description
    gave each patient 1000 mg, bid, PO
    Intervention Type
    Drug
    Intervention Name(s)
    Mecobalamin Tablets
    Intervention Description
    gave each patient 0.5 mg bid, PO
    Primary Outcome Measure Information:
    Title
    Changes in pulmonary function parameters
    Description
    The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,
    Description
    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
    Time Frame
    26 weeks
    Other Pre-specified Outcome Measures:
    Title
    Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat
    Description
    The quartus endpoints were the changes from baseline to week 26 in Systolic blood pressure,Diastolic blood pressure, and blood-fat
    Time Frame
    26 weeks
    Title
    Changes in retrobulbar hemodynamics (RI)
    Description
    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.
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiao-lin Jiang
    Organizational Affiliation
    Liaoning University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Lung Function in Patients With Early Type 2 Diabetes Mellitus

    We'll reach out to this number within 24 hrs