Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity

Conditions
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Prediabetes

Intervention / Treatment
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* Drug: Saxagliptin
* Drug: saxagliptin
* Drug: metformin
* Other: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Newly diagnosed insulin resistance or glucose intolerance . 2.20 to 70 years of age. 3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male). Exclusion Criteria: Under Diabetes Mellitus treatment. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors . Active heart failure. Unwilling or unable to sign inform consents.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standarddose Saxagliptin<br>Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months | Drug: Saxagliptin<br>* 5mg a day for 6 months<br>* Other names: Onglyza;|
| Active Comparator: Lifestyle intervention<br>Lifestyle intervention for 6 months | Other: lifestyle intervention<br>* lifestyle intervention for 6 months<br>* Other names: living way intervention;|
| Active Comparator: Metformin<br>Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months | Drug: metformin<br>* 500mg three times a day for 6 months<br>* Other names: melbine;|
| Experimental: low dose Saxagliptin<br>Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months | Drug: saxagliptin<br>* 2.5 mg a day for 6 months<br>* Other names: Onglyza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral glucose tolerance test |  | Change of Blood sugar from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saxagliptin, prediabetes, glucose intolerance,obesity