Sitagliptin for the Treatment of Type 2 Diabetes

NCT ID: NCT04495881

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-09-01

Brief Summary

Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.

Detailed Description

The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). This clinical trial aims to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the patients will be collected to analyze the gut microbiome. All of the patients will receive the sitagliptin treatment for 3 months. The gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

sitagliptin

sitagliptin 100mg

Group Type: EXPERIMENTAL

Sitagliptin 100mg

Intervention Type: DRUG

Sitagliptin 100mg Qd

Interventions

Sitagliptin 100mg

Sitagliptin 100mg Qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients 18-65 years old newly diagnosed with type 2 diabetes
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guang Wang

Professor and Director, Department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Liu, MD

Role: CONTACT

liujia0116@126.com

010-85231710

Yan Duan, MD

Role: CONTACT

010-85231711

Facility Contacts

Jia liu, MD

Role: primary

liujia0116@126.com

861085231710

References

Wang Q, An Y, Zhang L, Zhang Y, Wang G, Liu J. Regulation of Adropin by Sitagliptin monotherapy in participants with newly diagnosed type 2 Diabetes. BMC Endocr Disord. 2022 Dec 7;22(1):306. doi: 10.1186/s12902-022-01233-x.

Reference Type: DERIVED

PMID: 36476135 (View on PubMed)

Wang Q, Ma L, Zhang Y, Zhang L, An Y, Liu J, Wang G. Effect of Sitagliptin on Serum Irisin Levels in Patients with Newly Diagnosed Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Apr;12(4):1029-1039. doi: 10.1007/s13300-021-01023-z. Epub 2021 Feb 24.

Reference Type: DERIVED

PMID: 33625721 (View on PubMed)

Other Identifiers

2020-DM-Sitagliptin

Identifier Type: -

Identifier Source: org_study_id