Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

NCT ID: NCT02900417

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-11-30

Brief Summary

The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the composition of gut microbiota before and after the therapy of sitagliptin.

Detailed Description

The present study will included 9 newly diagnosed type 2 diabetic patient to receive sitagliptin 100mg daily for 12 weeks. These patients will receive 75g oral glucose tolerance test and fasting plasma glucose levels, lipids levels, fasting insulin levels and 2 hour post-load plasma glucose levels will be measured. Stool samples will be collected before the initiation of the use of sitagliptin. After 12 weeks, all patients will have fasting plasma glucose levels, lipids levels, fasting insulin levels tested. Stool samples will be collected again.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

sitagliptin

All the patients will receive sitagliptin 100mg daily.

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

All the patients will receive sitagliptin 100mg daily

Interventions

Sitagliptin

All the patients will receive sitagliptin 100mg daily

Intervention Type: DRUG

Other Intervention Names

Sitagliptin phosphate (Januvia; Merck)

Eligibility Criteria

Inclusion Criteria

• Newly-diagnosed type 2 diabetic patients aged between 40-70 years

Exclusion Criteria

• Any chronic disease (other than diabetes)
• Alcohol consumption/smoking
• Pregnancy/breastfeeding
• The use of antibiotics, pro-prebiotics within 3 months
• History of intestinal surgery

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Ji Hu

MD.,PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SecondSoochowU

Identifier Type: -

Identifier Source: org_study_id