Prediabetes
Conditions
Keywords
Saxagliptin, prediabetes, glucose intolerance,obesity
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.
Interventions
DRUGSaxagliptin
5mg a day for 6 months
DRUGsaxagliptin
2.5 mg a day for 6 months
DRUGmetformin
500mg three times a day for 6 months
OTHERlifestyle intervention
lifestyle intervention for 6 months
Sponsors
Chinese Medical Association
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
1. Under Diabetes Mellitus treatment. 2. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors . 3. Active heart failure. 4. Unwilling or unable to sign inform consents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oral glucose tolerance test | Change of Blood sugar from baseline at 6 months |
Countries
China
Contacts
Primary ContactXinli Zhou, MD,PhD
Outcome results
None listed