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Trial · NCT03613740

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryWaist Circumference (WC)12 weeks.WC was measured with a flexible tape at the midline between the highest point of the iliac crest and the lowest rib in the midaxillary line.
PrimaryFasting Serum Glucose12 weeks.Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
PrimaryTriglycerides (TG)12 weeks.TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
PrimaryHigh-Density Lipoprotein (HDL-C)12 weeks.Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
PrimarySystolic Blood Pressure12 weeks.Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm.
PrimaryDiastolic Blood Pressure12 weeks.Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm.
PrimaryMatsuda-DeFronzo Insulin Sensitivity Index12 weeks.
The Matsuda-DeFronzo index measures whole-body insulin sensitivity from serum insulin and glucose levels during an oral glucose tolerance test (OGTT). The index is calculated with the formula: 10,000 / sqrt(\[fasting glucose (mg/dL) × fasting insulin (µU/mL)\] × \[mean glucose × mean insulin during OGTT\]). The scale ranges from 0 to infinity, with higher values indicating greater insulin sensitivity. Typical values for healthy individuals range between 2 and 10, while lower values suggest insulin resistance.
PrimaryTotal Insulin Secretion12 weeks.
The Total Insulin Secretion is calculated as the ratio of the area under the curve (AUC) for insulin to the AUC for glucose during a 120-minute oral glucose tolerance test (OGTT). The formula is: AUC insulin / AUC glucose. AUC values are derived from concentrations measured at 0, 30, 60, 90, and 120 minutes post-ingestion of a glucose solution at week 12. Interpretation of the AUC insulin/AUC glucose ratio is as follows: values \<0.5 indicate insulin resistance, values between 0.5 and 1.0 suggest moderate insulin secretion, and values \>1.0 reflect optimal insulin secretion.
PrimaryStumvoll Index12 weeks.
The Stumvoll index measures the first phase of insulin secretion, incorporates demographic data along with plasma glucose (mmol/L) and insulin (pmol/L) levels measured during an oral glucose tolerance test (OGTT). There is no universally standardized ranges, values ranges from 0 to infinity; higher values indicate a better early insulin response to glucose (first 30 minutes), reflecting more effective beta-cell function.
SecondaryBody Weight12 weeks.Body weight was measured at baseline a bioimpedance scale.
SecondaryBody Mass Index (BMI)12 weeks.BMI was calculated with the Quetelet index formula.
SecondaryBody Fat12 weeks.Percentage of body fat was measured using a bioimpedance scale.
SecondaryTotal Cholesterol (TC)12 weeks.Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
SecondaryLow-Density Lipoprotein (LDL-C)12 weeks.Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + \[TG/5\])
SecondaryVery-Low-Density Lipoprotein (VLDL)12 weeks.Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5.
SecondaryAlanine Aminotransferase (ALT)12 weeks.Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
SecondaryAspartate Aminotransferase (AST)12 weeks.Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
SecondaryCreatinin12 weeks.Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

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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