NCT02583438

Brief Summary

The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.

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
100

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2015

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

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 14, 2015

Last Update Submit

October 21, 2015

Conditions

Type 2 DiabetesObesity

Keywords

Gut Microbiotainflammatory markerGlucose and lipid metabolism

Outcome Measures

Primary Outcomes (1)

  • gut microbiota

    Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months

Secondary Outcomes (2)

  • The improvement of intestinal microflora imbalance

    Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)

  • The change of inflammatory markers

    The change of inflammatory markers (baseline, 12 weeks)

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL
Drug: Saxagliptin (Bristol-Myers Squibb Company)

Interventions

Saxagliptin (Bristol-Myers Squibb Company)DRUG

6-month treatment of Saxagliptin 5mg Qd

Lifestyle intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females or males, and aged 20 to 65 years.
  • Newly diagnosed type 2 diabetes
  • HbA1C ≥7% and HbA1C \<9%

You may not qualify if:

  • Hepatic insufficiency (ALT or AST\> 1.5\*ULN)
  • Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation)
  • Coronary artery disease
  • Thyroid disease
  • Infectious disease
  • Systemic inflammatory disease
  • Cancer
  • Subjects who were taking agents known to influence gut microbiota
  • Pregnant or lactating woman
  • Other conditions at investigator's discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Endocrinology

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 22, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

October 22, 2015

Record last verified: 2015-10