Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583438
Recruitment Status : Unknown
Verified October 2015 by Guang Wang, Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Drug: Saxagliptin (Bristol-Myers Squibb Company) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beijing Chao-yang Hospital, Capital Medical University
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
Experimental: Lifestyle intervention Drug: Saxagliptin (Bristol-Myers Squibb Company)
6-month treatment of Saxagliptin 5mg Qd




Primary Outcome Measures :
  1. gut microbiota [ Time Frame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months ]

Secondary Outcome Measures :
  1. The improvement of intestinal microflora imbalance [ Time Frame: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks) ]
  2. The change of inflammatory markers [ Time Frame: The change of inflammatory markers (baseline, 12 weeks) ]
    The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Layout table for additonal information
Responsible Party: Guang Wang, Department of Endocrinology, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02583438    
Other Study ID Numbers: Saxa015
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Keywords provided by Guang Wang, Beijing Chao Yang Hospital:
Gut Microbiota
inflammatory marker
Glucose and lipid metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents