Trial · NCT03613740
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Waist 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. |
| Primary | Fasting Serum Glucose | 12 weeks. | Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | Triglycerides (TG) | 12 weeks. | TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | High-Density Lipoprotein (HDL-C) | 12 weeks. | Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | Systolic Blood Pressure | 12 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. |
| Primary | Diastolic Blood Pressure | 12 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. |
| Primary | Matsuda-DeFronzo Insulin Sensitivity Index | 12 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. |
| Primary | Total Insulin Secretion | 12 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. |
| Primary | Stumvoll Index | 12 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. |
| Secondary | Body Weight | 12 weeks. | Body weight was measured at baseline a bioimpedance scale. |
| Secondary | Body Mass Index (BMI) | 12 weeks. | BMI was calculated with the Quetelet index formula. |
| Secondary | Body Fat | 12 weeks. | Percentage of body fat was measured using a bioimpedance scale. |
| Secondary | Total Cholesterol (TC) | 12 weeks. | Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Secondary | Low-Density Lipoprotein (LDL-C) | 12 weeks. | Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + \[TG/5\]) |
| Secondary | Very-Low-Density Lipoprotein (VLDL) | 12 weeks. | Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5. |
| Secondary | Alanine Aminotransferase (ALT) | 12 weeks. | Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Secondary | Aspartate Aminotransferase (AST) | 12 weeks. | Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Secondary | Creatinin | 12 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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