Obesity
Conditions
Interventions
Test group:5mg or 10mg of proline Hanger-on and exercise diet treatment
Control group:Placebo and diet-exercise therapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: male or female =18 and =60 years of age 2: 28 kg/? = BMI = 38 kg/? 3: willing to adhere to the medication for 12 weeks 4: Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1: patients allergic to SGLT2 inhibitor drugs 2: Patients with diabetes mellitus such as type 2 diabetes 3: glomerular filtration rate (eGFR) 180 mmHg, diastolic blood pressure > 100 mmHg) despite oral antihypertensive medication 11: previous autoimmune, infectious, hepatic, gastrointestinal, malignant and uncontrolled psychiatric diseases 12: history of frequent urinary tract and genital tract infections (=3/year) 13: the need to take any medication that reacts with prolene Hanger-on, such as rifampin 14: Pregnant or breastfeeding patients, who have planned pregnancy within the last 1 year 15: patients who have participated in other clinical trials within 90 days 16: any condition that, in the judgment of the investigator, would jeopardize the assessment of efficacy or safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in each group who lost at least 5% of their body weight from baseline at week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute value of weight change from baseline for each group at week 12;Change in BMI from baseline for each group at week 12;Change in uric acid and creatinine from baseline in each group at week 12;Change in waist circumference from baseline in each group;Change in eGFR from baseline in each group at week 12;Change in HOMA-IR from baseline in each group;Percentage improvement in urinary albumin to creatinine ratio (UACR) from baseline for each group at weeks 4 and 12;Change in total 24-hour urinary glucose excretion from baseline in each group at weeks 2 and 12;Changes in blood lipids (including TG, TC, LDL-c, HDL-c) from baseline in each group;Change from baseline in sitting blood pressure in each group;Changes in inflammatory cells and C-reactive protein in each group relative to baseline at weeks 4 and 12;Change in blood ketones (ßhydroxybutyric acid) relative to basal values for each group at weeks 4 and 12;Percentage weight loss from baseline for each group at week 12; | — |
Countries
China
Contacts
Public ContactYe Shandong
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed