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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02900417
Enrollment
9
Registered
2016-09-14
Start date
2016-09-30
Completion date
2016-11-30
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, gut microbiota, sitagliptin

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.

Interventions

DRUGSitagliptin

All the patients will receive sitagliptin 100mg daily

Sponsors

Second Affiliated Hospital of Soochow University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The changes of the composition of gut microbiota before and after the use of sitagliptin12 weeks

Secondary

MeasureTime frame
Changes of HbA1c levels12 weeks
Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026