Type 2 diabetes mellitus with obesity
Conditions
Interventions
Control group:Metformin combined with placebo
Experimental group:Metformin combined with ProSci-246
Sponsors
Weihai Municipal Hospital Affiliated to Shandong University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Basic demographic characteristics: Age 40–75 years, both males and females eligible; Body Mass Index (BMI): = 28 kg/m². 2. Diabetes-related indicators: Confirmed diagnosis of type 2 diabetes mellitus; Random blood glucose = 11.1 mmol/L; Fasting blood glucose = 7.0 mmol/L; 2-hour OGTT plasma glucose = 11.1 mmol/L; HbA1c = 6.5%; No use of other antidiabetic drugs or discontinuation for at least 4 weeks (washout period). 3. Metabolic complications: Concurrent obesity-related metabolic abnormalities (such as hypertension, dyslipidemia, hyperuricemia) are permitted, provided they meet the cardiovascular, hepatic, and renal restrictions specified in the exclusion criteria.Agree to participate in this study and sign the informed consent form. 4. The patient is conscious and able to cooperate, either independently or with the help of family members, in completing examinations, questionnaire surveys, medical history collection, etc.
Exclusion criteria
Exclusion criteria: 1. History of other types of diabetes mellitus: exclusion of type 1 diabetes mellitus, monogenic diabetes, or other secondary diabetes (e.g., Cushing's syndrome, thyroid dysfunction, etc.); 2. History of medication use: use of weight-loss drugs, corticosteroids, probiotics/prebiotics within the past 3 months; frequent use of antibiotics (cumulative use = 3 days within the past 3 months); 3. Health status: severe cardiovascular disease (e.g., cardiac function = NYHA class III, uncontrolled stage III hypertension); hepatic or renal dysfunction (ALT/AST > 2.5 times the upper limit of normal, or eGFR < 45 mL/min/1.73 m²); gastrointestinal diseases or gastrointestinal surgery within the past 1 year; active infection, history of malignancy (within 5 years), severe dementia, psychiatric disorders, or infectious diseases (e.g., hepatitis B, HIV); 4. Others: pregnant, breastfeeding, or planning pregnancy; body weight fluctuation = 5 kg within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin;Blood Glucose;Insulin;C-Peptide;Hamilton Anxiety Rating Scale;Hamilton Depression Rating ;Mini-Mental State;Montreal Cognitive ;Pittsburgh Sleep Quality Index;Visual Analogue Score;Body composition;Gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Cholesterol;Triglyceride;Low-Density Lipoprotein Cholesterol;High-Density Lipoprotein Cholesterol;Lipoprotein A;Homeostasis Model Assessment of Insulin Resistance;Insulinogenic Index;Triglyceride-Glucose Index;Triglyceride-Glucose-Waist Circumference Index;Triglyceride-Glucose-Waist-to-Height Ratio Index;Triglyceride-to-High-Density Lipoprotein Cholesterol Ratio;Metabolic Score for Insulin Resistance;Chinese Visceral Adiposity Index;OSAS Risk Screening Questionnaire;Low-Density Neutrophil (LDN) Frequency;Calprotectin;Fecal Calprotectin;Plasma Metabolite ;Fecal Metabolite ; | — |
Countries
China
Contacts
Public ContactZhang Jinbiao, Chi Haiyan
Weihai Municipal Hospital Affiliated to Shandong University
Outcome results
None listed