Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2021
CompletedFirst Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJune 9, 2022
June 1, 2022
1.3 years
February 10, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (2)
change in HbA1c
3 months
body weight
3 months
Other Outcomes (8)
changes in waist circumference
3 months
changes in hip circumference
3 months
changes in neck circumference
3 months
- +5 more other outcomes
Study Arms (2)
life intervention group
PLACEBO COMPARATOROn 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.
nutritional supplement intervention group
EXPERIMENTALOn 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.
Interventions
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.
Patients will receive lifestyle interventions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ningbo First Hospital
Ningbo, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 10, 2022
Study Start
June 11, 2021
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
June 9, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share