Clinical trial NCT05273840: Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
Official title: Effect of Nutritional Supplements (Ivital Control) on Clinical Outcomes in Patients With Prediabetes and Obesity：a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Obesity
Keywords: PreDiabetes
Obesity
Glycosylated hemoglobin
weight
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. life intervention group
2. nutritional supplement intervention group
Primary purpose: PREVENTION

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.)

Primary outcomes:
measure: the proportions of participants regressing back to normal glucose level
timeFrame: 3 months
Secondary outcomes:
measure: change in HbA1c
timeFrame: 3 months
measure: body weight
timeFrame: 3 months
Other outcomes:
measure: changes in waist circumference
timeFrame: 3 months
measure: changes in hip circumference
timeFrame: 3 months
measure: changes in neck circumference
timeFrame: 3 months
measure: changes in visceral fat area
timeFrame: 3 months
measure: changes in body fat percentage
timeFrame: 3 months
measure: changes in lean mass
timeFrame: 3 months
measure: blood lipids
timeFrame: 3 months
measure: changes in triglyceride level (blood lipids)
timeFrame: 3 months
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
Study officials:
References: