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

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ClinicalTrials.gov Identifier: NCT02900417
Recruitment Status : Unknown
Verified September 2016 by Ji Hu, Second Affiliated Hospital of Soochow University.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Ji Hu, Second Affiliated Hospital of Soochow University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
Study Start Date : September 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sitagliptin
All the patients will receive sitagliptin 100mg daily.
Drug: Sitagliptin
All the patients will receive sitagliptin 100mg daily
Other Name: Sitagliptin phosphate (Januvia; Merck)




Primary Outcome Measures :
  1. The changes of the composition of gut microbiota before and after the use of sitagliptin [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Ji Hu, MD.,PhD., Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02900417     History of Changes
Other Study ID Numbers: SecondSoochowU
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ji Hu, Second Affiliated Hospital of Soochow University:
type 2 diabetes
gut microbiota
sitagliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action