Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT05667220
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief Summary
The study was an interventional non-randomized controlled study and was divided into a Sitagliptin monotherapy (100 mg Qd) group and a Sitagliptin (100mg Qd)+Beidougen capsule (60mg Tid) combination treatment group for one week.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients aged 18-65 years with a first diagnosis of type 2 diabetes
- Diagnostic criteria HbA1c ≥ 7%
- The positive of diabetes antibodies
- Anti-diabetic drugs therapy before participation
- Pancreatitis
- Coronary artery disease
- Liver function impairment
- Renal function impairment
- History of intestinal surgery
- Chronic hypoxic diseases (emphysema and cor pulmonale)
- Infectious disease
- Hematological disease
- Systemic inflammatory disease
- Cancer
- Pregnant
- Ingesting agents known to influence glucose or lipid metabolism
- Any antibiotics or probiotics in the past three months prior to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin combined with Beidougen capsule treatment group (Group B) Sitagliptin combined with Beidougen capsule - Sitagliptin monotherapy group (Group A) Sitagliptin -
- Primary Outcome Measures
Name Time Method Fasting blood glucose change Changes in fasting blood glucose from baseline to 1 week treatment Fasting blood glucose (FBG) levels (mmol/L) were analyzed by an autoanalyzer (Hitachi 747, Roche Diagnostics, Germany) at the Central Chemistry Laboratory of Beijing Chaoyang Hospital affiliated with Capital Medical University.
- Secondary Outcome Measures
Name Time Method Serum GLP-1 change Changes in serum GLP-1 from baseline to 1 week treatment The serum active GLP-1 contents were measured using an active GLP-1 assay kit (EZGLPHS-35K, Millipore) according to the specification.
Fecal DPP4 activity change Changes in fecal DPP4 activity from baseline to 1 week treatment For measurement of fecal DPP4 activity, 60 mg feces were homogenized in RIPA lysis buffer (with final concentration at 1 mg/mL) was added to 50 mM sodium phosphate buffer (pH = 7.4, OD600 = 0.5), and the reaction was started by the addition of 250 μM H-A-pNA. After incubation for 30 min at 37 °C, the absorbance was measured at 405 nm.
Trial Locations
- Locations (1)
Beijing Chao-yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China