Type 2 Diabetes
Conditions
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.
Interventions
DRUGSitagliptin
Sitagliptin monotherapy group (Group A): 20 eligible patients were planned to be included and given Sitagliptin 100 mg Qd orally; the treatment period was 1 week.
DRUGSitagliptin combined with Beidougen capsule
Sitagliptin combined with Beidougen capsule treatment group (Group B): 20 eligible patients were planned to be included and given sitagliptin 100mg Qd orally combined with Beidougen capsule 60mg Tid orally. The treatment period was 1 week.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-65 years with a first diagnosis of type 2 diabetes * Diagnostic criteria HbA1c ≥ 7%
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJia Liu, MD
Backup ContactYan Duan, MD
Outcome results
None listed