Çin Halkında (Diyabet Hastaları Dahil) DPP-4 ve GLP-1R'nin SNP Çalışması

Sade dilde özet

Bu çalışma, tip 2 diyabet (type 2 diabetes) hastaları dahil olmak üzere Çin halkında DPP-4 ve GLP-1R genlerindeki genetik farklılıkların (SNP) ve Sitagliptin ilacına verilen yanıtın incelenmesini amaçlamaktadır. Çalışmaya, 40-70 yaş arası tip 2 diyabet hastaları ve ayrıca diyabeti olmayan bir grup katılabilmiştir. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Sichuan Provincial People's Hospital

Müdahale

Sitagliptin

Başlangıç

21.04.2016

Tahmini bitiş

08.10.2018

Ülkeler

China

İlgili genler

Merkezler

• Chengdu, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.