Trial · NCT01030952
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | 3 weeks (end of study) minus baseline | The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. 0-4 hours AUC were calculated using trapezoid methods. |
| Secondary | Change in Incremental Glucose Peak (IGP) From Baseline | baseline, 3 weeks (end of study) | Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal |
| Secondary | Change in Mean Blood Glucose (MBG) | baseline and at 3 weeks (end of study) | The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately. |
| Secondary | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | baseline, 3 weeks (end of study) | Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours. |
| Secondary | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | baseline, 3 weeks (end of study) | The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability. |
| Secondary | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | baseline, end of study (3 weeks) | Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. |
| Secondary | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | baseline, 3 weeks (end of study) | GSA levels were to be determined by CGMS at 7:00\~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments |
| Secondary | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | baseline, 3 weeks (end of study) | This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes |
| Secondary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | baseline, 3 weeks (end of study) | change in LDL-C at 0, 30 and 120 minutes |
| Secondary | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | baseline, 3 weeks (end of study) | time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes |
| Secondary | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | baseline, 3 weeks (end of study) | TG change in blood lipids level from baseline to endpoint |
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | baseline, 3 weeks (end of study) | Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value. |
| Secondary | Change in Mean Amplitude of Glycaemic Excursion (MAGE) | baseline, 3 weeks (end of study) | mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size |
| Secondary | The Percent of 24 Hour Hypoglycemic Measurements | baseline, 3 weeks (end of study) | Measures/compares changes in percentage of hypoglycemia(\<3.9mmol/l or \<70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values \[100% \* ((X-Y)/Y)\] |
| Secondary | Change in Percent of 24 Hour Hyperglycemic Measurements | baseline, 3 weeks (end of study) | Measures/compares changes in percentage of hyperglycemia (\>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values \[100% \* ((X-Y)/Y)\] |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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