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Effect of Henagliflozin Proline Tablets on visceral fat area in type 2 diabetic patients

Effect of Henagliflozin Proline Tablets on visceral fat area in type 2 diabetic patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085789
Enrollment
Unknown
Registered
2024-06-18
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

treatment group:conventional treatment regimen (Combined or unconjugated insulin, except for GLP-1 receptor agonists)+ Henagliflozin Proline
control group:Other hypoglycemic drugs (excluding SGLT2 inhibitors and GLP-1 receptor agonists)

Sponsors

Maanshan General Hospital of Ranger-Duree Healthcare
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?In accordance with the diabetes diagnostic criteria and T2DM classification criteria established by WHO in 1999;?Use traditional oral hypoglycemic drugs or insulin to control blood sugar, HbA1c: 7-10%; No SGLT-2i and GLP-1 receptor agonists were used within 4 weeks; ?Age 30-70 years old;?BMI=23 kg/m2

Exclusion criteria

Exclusion criteria: ?Patients with type 1 diabetes or special types of diabetes; ?Patients with acute complications such as ketoacidosis;?Use of SGLT-2i or GLP-1 receptor agonists within 4 weeks or currently; ?Patients with acute stress, severe trauma, severe infection, or who are being treated with glucocorticoids; ?Patients with acute myocardial infarction, cardiac insufficiency (NYHAIII or above), cerebral hemorrhage, cerebral thrombi, and obvious abnormal liver and kidney function (ALT and AST> 3 times the upper limit of normal, estimated glomerular filtration rate (eGFR)=30mL/min/ 1.73m2); ?History of frequent urinary and reproductive tract infections (=3 times/year);?Pregnant or nursing patients, who have pregnancy plans in the past 1 year; ?People who are allergic to relevant drugs.

Design outcomes

Primary

MeasureTime frame
Visceral fat area;

Secondary

MeasureTime frame
Subcutaneous fat area;Waist circumference and waist to hip ratio;Blood pressure, FPG, HbA1c, hypersensitive C-reactive protein, blood lipid indicators, liver and kidney function indicators, BMI;

Countries

China

Contacts

Public ContactJun Zhu

Department of Endocrinology, Maanshan General Hospital of Ranger-Duree Healthcare

zhujunzjzj@163.com+86 181 5553 2111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026