Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
1 other identifier
interventional
80
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
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
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 7, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
1.3 years
October 7, 2013
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oral glucose tolerance test
Change of Blood sugar from baseline at 6 months
Study Arms (4)
Standarddose Saxagliptin
EXPERIMENTALSaxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months
Lifestyle intervention
ACTIVE COMPARATORLifestyle intervention for 6 months
Metformin
ACTIVE COMPARATORMetformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months
low dose Saxagliptin
EXPERIMENTALSaxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months
Interventions
lifestyle intervention for 6 months
Eligibility Criteria
You may qualify if:
- Newly diagnosed insulin resistance or glucose intolerance .
- to 70 years of age.
- BMI≥28kg/m2，or BMI\>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).
You may not qualify if:
- Under Diabetes Mellitus treatment.
- Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
- Active heart failure.
- Unwilling or unable to sign inform consents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Provincial Hospitallead
- Chinese Medical Associationcollaborator
Study Sites (1)
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Related Publications (1)
Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.
PMID: 28575729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinli Zhou, MD, PhD
Shandong Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xinli Zhou
Study Record Dates
First Submitted
October 7, 2013
First Posted
October 10, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09