Clinical trial NCT04495881: Sitagliptin for the Treatment of Type 2 Diabetes
Official title: Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: HbA1c change
timeFrame: Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Secondary outcomes:
measure: fasting blood glucose change
timeFrame: Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
measure: HOMA-IR change
timeFrame: Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
measure: Glycated Albumin（GSA）change
timeFrame: Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Guang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.