Viewing Study NCT01960205


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Study NCT ID: NCT01960205
Status: UNKNOWN
Last Update Posted: 2014-09-25
First Post: 2013-10-07
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Sponsor: Shandong Provincial Hospital
Organization:

Study Overview

Official Title: Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
Status: UNKNOWN
Status Verified Date: 2014-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
Detailed Description: Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.

Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: