Status:
UNKNOWN
Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
Lead Sponsor:
Ningbo No. 1 Hospital
Conditions:
PreDiabetes
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical fol...
Eligibility Criteria
Inclusion
- According to the American Diabetes Society (ADA) 2010 standard: meet one of the following (1) fasting blood glucose at 100 mg/dl to 125 mg/dl; (2) sugar load 2h blood glucose at 140 mg/dl to 199 mg/dl; (3) glycosylated hemoglobin in 5.7% to 6.4%
- Body mass index (BMI) ≥ 25 and ≤ 35kg/m2
- Have lived locally for at least half a year and have a fixed residence
- No other clinical trials were participated in in the 3 months prior to the trial
- Mental health, being able to take care of oneself in life
Exclusion
- People with confirmed diabetes
- Weight change of more than 10% over the past 3 months
- Pregnant or lactating women, men and women planning to become pregnant within two years, or unwilling and unable to use contraception during the study period (women only)
- People who are allergic to the ingredients of nutritional supplements
- Those who have lost weight by any medication (including appetite suppressants such as fluprophenylpropanine, progesterone, laxatives, etc., and diet pills with various Traditional Chinese medicine ingredients) or surgery in the past 3 months
- Patients who have received medical treatment for the following diseases in the past 3 months: diabetes, cholecystitis, peptic ulcer, inflammatory bowel disease, acute urinary tract infection, hyperthyroidism, etc., or patients with chronic gastrointestinal diseases with symptoms of nausea, vomiting and diarrhea in the past month
- Suffer from severe organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke
- Presence of pituitary-adrenal axis dysfunction; secondary obesity due to other diseases (e.g., Cushing syndrome, hypothyroidism, etc.)
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05273840
Start Date
June 11 2021
End Date
November 1 2022
Last Update
June 9 2022
Active Locations (1)
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1
Ningbo First Hospital
Ningbo, China