SNP Study of DPP-4 and GLP-1R in Chinese People (Including Diabetes Patients)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Sitagliptin
Intervention description: 100mg.QD for 3 months
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DPP-4; GLP1R ; gene polymorphism research; diabetes

Summary:

      Incretin-based therapy is currently one of the most popular diabetes treatment approaches.
      However, differences of response ware found in previous studies. We hypothesis that SNPs of
      DPP-4, GLP-1 and GLP-1R genes may play crucial roles in the response differences. Therefore,
      this study aims to investigate the correlation of incretin-related gene polymorphism and
      individual differences in the response of DPP-4 inhibators (take Sitagliptin as an example).
      In addition, The distribution differences of the SNPs in diabetics and non-diabetics are
      evaluated to study the relationships between the SNPs and diabetes onsets.
    

Eligibility criteria:

        For Sitagliptin group--

        Inclusion Criteria:

          1. According to diagnostic criteria from Chinese type 2 diabetes prevention and treatment
             guidelines in diabetes, that published in the Chinese Medical Association Diabetes
             credits in 2010: Symptoms of diabetes (polydipsia, polyphagia, polyuria, weight loss,
             itchy skin, blurred vision and other acute metabolic disorders performance caused by
             hyperglycemia) and RBG≥11.1mmol/L, or fasting plasma glucose (FPG)≥7.0mmol/L, or
             plasma glucose of 2 hours post glucose-load≥11.1 and patients diagnosed with type 2
             diabetes; HbA1c in the range of 7%-10%;

          2. Age 40-70 years;

          3. Body Mass Index(BMI) 18-40;

          4. Did not accepted any antihyperglycemic therapies during the past 4 weeks, or did not
             change their antihyperglycemic treatment plan in the past 3 months;

          5. Did not participate in clinical trials within three months;

          6. No serious heart, brain, liver and kidney disease;

          7. Signed informed consent.

        Exclusion Criteria:

          1. Have taken any incretin drugs within recent 1 month;

          2. Patients with a weakened immune system;

          3. C-peptide < 0.3ng/ml;

          4. GLP-1 and DPP4-i drugs allergies;

          5. Pregnancy and breast-feeding patients;

          6. Patients taking drugs that may affect the metabolism of GLP-1 and DPP4;

          7. Patients have serious heart, liver, kidney and respiratory dysfunction; Patients have
             medullary thyroid carcinoma (MTC) with past history or family history, as well as
             multiple endocrine neoplasia type 2 syndrome (MEN2);

          8. Drug abusing and alcoholism within a year.

        For non-T2D group--

        No major diseases such as tumors, no dyslipidemia, chronic diseases such as hypertension,
        and non-diabetic patients whose blood sugar and glycated hemoglobin values cannot meet the
        criteria for diagnosis of T2DM, and the age is over 50 years old.