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NCT02900417 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02900417
Other study ID # SecondSoochowU
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 30, 2016
Last updated September 8, 2016
Start date September 2016
Est. completion date November 2016

Study information
Verified date September 2016
Source Second Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 9
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Sitagliptin
All the patients will receive sitagliptin 100mg daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital of Soochow University

Outcome
Type Measure Description Time frame Safety issue
Primary The changes of the composition of gut microbiota before and after the use of sitagliptin 12 weeks No
Secondary Changes of HbA1c levels 12 weeks Yes
Secondary Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity 12 weeks Yes
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