NCT02900417

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable type-2-diabetes

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

August 30, 2016

Last Update Submit

September 8, 2016

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesgut microbiotasitagliptin

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (2)

  • Changes of HbA1c levels

    12 weeks

  • Changes of fasting plasma glucose levels, lipids levels and insulin sensitivity

    12 weeks

Study Arms (1)

sitagliptin

EXPERIMENTAL

All the patients will receive sitagliptin 100mg daily.

Drug: Sitagliptin

Interventions

SitagliptinDRUG

All the patients will receive sitagliptin 100mg daily

Also known as: Sitagliptin phosphate (Januvia; Merck)
sitagliptin

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.,PhD.

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09