Familial adenomatous polyposis
Conditions
Interventions
Metformin group:Metformin 500mg bid for 1 year starting after the first endoscopy test.
Celecoxib group:Celecoxib 400mg bid for 1 year starting after the first endoscopy test
two-drug combination group:Metformin (500 mg bid) in combination with celecoxib (400 mg bid) for 1 year starting after the first endoscopy test
Sponsors
900th Hospital of the Joint Logistics Force, People's Liberation Army, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients >=18 years old who meet the clinical diagnostic criteria for FAP; 2.1 of the following is sufficient: I. An intact colon with moderate adenomatous load (100 to 1000 adenomatous polyps); II. Surgical treatment, including subtotal colectomy + ileoanal anastomosis and ileocecal pouch-anal tube anastomosis.
Exclusion criteria
Exclusion criteria: I. Hypersensitivity to NSAIDs, sulfonamides, and salicylates; II.Elevated C-reactive protein (>3.0 mg/L); III. History of cardiovascular disease or any of the following conditions, including myocardial infarction, angina pectoris, coronary angioplasty, congestive heart failure, stroke or coronary artery bypass grafting surgery, and hypertension that is not effectively controlled; IV. Use of non-steroidal anti-inflammatory drugs more than 3 times per week, long-term use of glucocorticoids during the 6 months prior to the trial; V. Diagnosis of malignant disease, such as CRC; VI. Diagnosis of diabetes mellitus, pregnancy or breastfeeding; VII. Significantly abnormal results of liver and kidney function tests, or major infections, respiratory diseases, peptic ulcers, etc; VIII.Men who are preparing for pregnancy; IX. Patients who, in the opinion of the investigator, have inappropriate enrollment factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and load of polyps;Pathologic manifestations of polyps and degree of heterogeneous proliferation;Endoscopic picture of colorectal adenoma;Video of endoscopic manipulation of colorectal adenomas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood test;Coagulation;Blood urea nitrogen;Fasting insulin;Glycosylated hemoglobin;Blood creatinine;Total cholesterol;Low density lipoprotein (LDL);Glutamic oxaloacetic transaminase;Glutamic-pyruvic transaminase;fasting blood glucose; | — |
Countries
China
Contacts
Public ContactLi Dazhou
00th Hospital of the Joint Logistics Force, People's Liberation Army, China
Outcome results
None listed