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Lung Function in Patients With Early Type 2 Diabetes Mellitus

NCT03167918 — Phase 2 / Phase 3, Completed, 200 participants, Liaoning University of Traditional Chinese Medicine

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Liaoning University of Traditional Chinese Medicine

RegistryNCT03167918
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment200 (Actual)
SponsorLiaoning University of Traditional Chinese Medicine (Other)
ConditionsType 2 Diabetes Mellitus, Pulmonary Function
InterventionsCalcium Dobesilate, Xuefuzhuyu Decoction, Xuefuzhuyu Decoction & Calcium dobesilate, metformin, Mecobalamin Tablets (Drug)
Datesstart 2014-07-21, primary completion 2017-04-01, completion 2017-05-01, first posted 2017-05-30, last updated 2017-05-30

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-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Calcium dobesilateExperimentalDrug: Calcium Dobesilate; Drug: metformin; Drug: Mecobalamin Tabletsgave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO
Xuefuzhuyu DecoctionExperimentalDrug: Xuefuzhuyu Decoction; Drug: metformin; Drug: Mecobalamin Tabletsgave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid,po
Xuefuzhuyu Decoction &Calcium dobesilateExperimentalDrug: Xuefuzhuyu Decoction & Calcium dobesilate; Drug: metformin; Drug: Mecobalamin Tabletsgave 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 (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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Other outcomes

  • Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat [26 weeks]: The quartus endpoints were the changes from baseline to week 26 in Systolic blood pressure,Diastolic blood pressure, and blood-fat
  • Changes in retrobulbar hemodynamics (RI) [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.

+Eligibility

Sex: All, accepts 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.

+Investigators

  • Xiao-lin Jiang, Principal investigator, Liaoning University of Traditional Chinese Medicine

My Notes