Obesity Clinical Trial
Official title:
Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes
In Korea, 5 million adults aged 30 years or older have diabetes. The development and
expansion of Korea's economy and society, has led to dramatic chances in people's lifestyle
and diet habits, and an increase in life expectancy. However, changes in lifestyle and diet
habits related to the improvements of socioeconomic status may contribute to an increased
diabetes burden in Korea. Therefore, it is important to prevent diabetes.
The purpose of this study was to evaluate the effects of real time-continuous glucose
measurement (RT-CGM) system compared to only lifestyle modification group on blood glucose,
lipid profile and diabetes prevention in prediabetic adults with overweight or obesity.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - = BMI 23 kg/m2 - impaired fasting glucose (fasting glucose 100 to 125 mg/dL) or impaired glucose tolerance (2-h plasma glucose during oral glucose tolerance test (OGTT) 140 - 199 mg/dl) or HbA1c 5.7% to 6.4% Exclusion Criteria: - type 1 diabetes or type 2 diabetes or undergoing treatment for diabetes - clinical history including malignancy - fast history of cardiovascular disease (e.g. myocardial infarction, stroke), surgery, and trauma which may affect blood glucose within last 6 months - taking medication (e.g. glucocorticoid, antipsychotics, anticholinergic drug etc.) which affect blood glucose - acute infection within last 1 month - pregnancy |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jeong Mi Kim | Busan |
Lead Sponsor | Collaborator |
---|---|
Pusan National University Hospital |
Korea, Republic of,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1C change | All participants receive lifestyle intervention at week 0, week 4, and week 8. The intervention group was monitored initial 1 weeks with a RT-CGM and th control group continued self-monitoring blood glucose (SMBG) at least 2 times a day for 1 week. HbA1c at baseline (week 0) and end of intervention (week 12). |
Outcomes were assessed at baseline (week 0) and end of intervention (week 12) | |
Primary | Weight (Kg) change | weight change (Kg) at baseline (week 0) and end of intervention (week 12) | baseline (week 0) and end of intervention (week 12) | |
Secondary | lipid profile | both groups were assessed fasting lipid profile (total cholesterol, triglyceride and HDL-cholesterol) at baseline (week 0) and end of intervention (week 12) | baseline (week 0) and end of intervention (week 12) |
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