An interventional study of Ivital Control and lifestyle intervention in PreDiabetes and Obesity, sponsored by Ningbo No. 1 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Prevention
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 follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. All enrolled participants were recommended for routine diabetes lifestyle education according to the "Expert Consensus on Prediabetes Intervention in Adults in China". The duration of the intervention was 3 months. The investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. In addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Ningbo No. 1 Hospital is the lead sponsor of 56 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given to the patients until the end of the visit.
Behavioral: lifestyle intervention
On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given, and at the same time, nutritional supplements(Ivital Control) are given to instead a meal per day. 2 bags once a day until the end of the visit.
Dietary Supplement: Ivital Control
Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions.
Also known as: Produced by Fresenius Kabi, Chocolate flavor, Product specifications: 460g (46g*10)
Patients will receive lifestyle interventions.
the proportions of participants regressing back to normal glucose level
The normal glucose level was defined as FPG \< 6.1 mmol/L and 2hPG \< 7.8 mmol/L during the OGTT.
Time frame: 3 months
change in HbA1c
change in HbA1c
Time frame: 3 months
body weight
changes in body weight
Time frame: 3 months
changes in waist circumference
anthropometric parameters
Time frame: 3 months
changes in hip circumference
anthropometric parameters
Time frame: 3 months
changes in neck circumference
anthropometric parameters
Time frame: 3 months
changes in visceral fat area
body composition
Time frame: 3 months
changes in body fat percentage
body composition
Time frame: 3 months
changes in lean mass
body composition
Time frame: 3 months
blood lipids
changes in LDL-cholesterol, HDL-cholesterol
Time frame: 3 months
changes in triglyceride level (blood lipids)
changes in triglyceride
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Ningbo No. 1 Hospital