Status:
UNKNOWN
Mobile Internet Healthcare and Three Disciplines Co-management Intervention for Overweight/Obese Prediabetic Patients
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Overweight/Obesity
Prediabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Diabetes mellitus is a chronic metabolic disease associated with a high rate of disability and mortality. Prediabetes is the intermediate stage from normal blood glucose to diabetes. Reversal of predi...
Detailed Description
Sample size estimation The sample size was calculated based on the primary clinical endpoint and previous relevant clinical studies, which met 90% detection efficacy, with an a-value of 0.05 on both s...
Eligibility Criteria
Inclusion
- ①18 years≤ Age\<70 years
- 7mmol/L≤ fasting blood glucose \<6.9mmol/L
- 8mmol/L≤2h blood glucose \<11.0mmol/L;
- 24Kg/m2≤BMI≤45Kg/m2
Exclusion
- Diagnosed diabetes
- In the past 3 months, metformin, thiazolidinedione, acarbose and weight reduction drugs were used
- Severe infection, severe trauma or other stress
- The weight fluctuation in the past 3 months was \>5%
- Aspartate Transaminase(AST) or Alanine Aminotransferase（ALT） increased the upper limit of 3 times the normal value; Creatinine greater than 1.5 times the upper limit of normal; Estimated Glomerular Filtration Rate（eGFR） 30 ml/min / 1.73 m2 or less
- Serious cardiovascular and cerebrovascular disease in the past 6 months
- Abnormal thyroid function not controlled;
- Pregnant and breastfeeding women
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06147752
Start Date
March 28 2023
End Date
March 1 2025
Last Update
November 28 2023
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003