Obese patients with type 2diabetes
Conditions
Interventions
Control group:Sigliptin treatment
experimental group:week 0-week 12,Mulberry total alkaloid tablet treatment
Sponsors
First Hospital of Shanxi medical university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 and = 28 kg/m2; 4. HbA1c<9%; 5.treatment without glucose-lowering agent(s) during the 3 months before the screening visit, or received a stable dose of metformin for at least 3 months before randomization Be able to understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) weight loss ?5% during the previous 6 months prior to the study 2) secondary obesity-related diseases,including Cushing syndrome, hypogonadism, growth hormone deficiency, hypothalamic disorders,Pseudohypoparathyroidism,insulinoma,hypothyroidism,etc, excluding patients with hypothyroidism were euthyroid (normal free T4 and TSH) on thyroid hormone replacement at the time of evaluation for 3 months. 3)patients who had previous gastric or bariatric surgery, such as endoscopic resection or partial surgical resection, astrectomy, reconstruction or operation OR resection OR surgery, CABG coronary artery bypass graft during the previous 6 months prior to the study (coronary artery bypass graft, carotid bypass graft, peripheral vascular diseases), patients undergoing appendectomy, andhernia repair, diagnostic angiography with a large ventral hernia, large hiatal hernia, or removal of adjustable gastric band and removal of adjustable gastric band within 12 months. 4) Patients with diseases that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, and intestinal ulcers); 5) Combined use of drugs that affect weight, such as Sibutramine Hydrochloride, Olistatin, Phenylbutylamine, Phenylpropanolamine, Chlorphenicol Indole, Fentigmine, Anfilazone, Chlorcaselin, Fentigmine/Topiramate Mixture, Natrexone/Bupropion Mixture, etc; Corticosteroids (oral, injection, inhalation): prednisone, methylprednisolone, dexamethasone, hydrocortisone, budesonide, cyclosonide, fluticasone;Antipsychotic drugs: antidepressants (amitriptyline, noramitriptyline, imipramine, demethylimipramine, trimethylimipramine, doxepin, sertraline, paroxetine, fluoxetine, mirtazapine, citalopram, fluvoxamine), antipsychotic drugs (chlorpromazine, fluphenazine, thiazidine, haloperidol, losapine, clozapine, olanzapine, risperidone, quetiapine);Over the counter weight loss pills, participating in organized weight loss programs (such as WeightWatchers, Noom), or using weight loss products (Chinese herbal medicine, health products, meal substitutes); 6)A participant was ineligible for participation in the study if any of the following criteria were met:liver disease, ALT or AST > 2 ULN, or TBIL > 1.5 ULN, ad the diagnosis was confirmed within one week;Patients with impaired renal function (eGFR= 160mmHg and/or DBP >= 100mmHg) with or without antihypertensive medications; 8)Those with severe diabetic complications;patients with hyperglycemic crises present with combined features of diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) and lactic acidosis; 9)12 lead electrocardiogram shows baseline heart rate500ms, left or right bundle branch block, baseline heart rate>100 beats/min, supraventricular tachycardia or tachycardia (such as atrial fibrillation, atrial flutter or ventricular tachycardia), and preexcitation syndrome; 10)Recent cardiovascular and cerebrovascular events;Suffering from congestive heart failure, decompensated heart failure (NYHA grade III-IV), electrocardiogram showing left ventricular hypertrophy, myocardial infarction, unstable angina (such as CCS grade III and IV angina), transient ischemic attack, and cerebrovascular accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body mass index; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;Visceral Fat Area;waist;fasting and 2 hour postprandial blood insulin;Peripheral blood monocyte;genetic detection;hipline ;calf circumference; | — |
Countries
China
Contacts
Public ContactWang Yan
First Hospital of Shanxi medical university
Outcome results
None listed