CClinicalTrials.gg
Status unknownNCT02900417Updated Sep 14, 2016

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

An interventional study of Sitagliptin in Type 2 Diabetes, sponsored by Second Affiliated Hospital of Soochow University. Status unknown. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-09-14.

Sponsored by Second Affiliated Hospital of Soochow University · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • type 2 diabetes
  • gut microbiota
  • sitagliptin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    sitagliptin

    All the patients will receive sitagliptin 100mg daily.

    Drug: Sitagliptin

Interventions

  • DrugSitagliptin

    All the patients will receive sitagliptin 100mg daily

    Also known as: Sitagliptin phosphate (Januvia; Merck)

06

What researchers measure

Primary outcomes

  1. The changes of the composition of gut microbiota before and after the use of sitagliptin

    Time frame: 12 weeks

Secondary outcomes

  1. Changes of HbA1c levels

    Time frame: 12 weeks

  2. Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02900417
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
Ji Hu (MD.,PhD., Second Affiliated Hospital of Soochow University) — Principal investigator
First posted
Sep 14, 2016
Start date
Sep 2016
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Sep 14, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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