Trial · NCT02330549
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Matsuda Index | Baseline (Day 1) to Weeks 12 and 24 | Change in peripheral insulin sensitivity was measured by the Matsuda Index. Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index. Matsuda Index=10,000/square root \[FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)\]. A Matsuda index of \<2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
| Primary | Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Baseline (Day 1) to Weeks 12 and 24 | Change in adipose insulin sensitivity was measured by Adipo-IR. Adipo-IR= (Fasting Serum free fatty acid (FFA) mmol/L x FPI μIU/mL). A higher Adipo-IR index indicates the worst disease state. A lower Adipo-IR Index is best. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | Macrophage infiltration in adipose tissue was assessed in paraffin-embedded adipose punch biopsies by immunohistochemistry stained for cluster of differentiation 68 (CD68), cluster of differentiation 163 (CD163), C-C chemokine receptor type 2 (CCR2), C-C chemokine receptor type 5 (CCR5) and cluster of differentiation 206 (CD206). A reduction in infiltration indicates less inflammation. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | CCR2 and CCR5 corresponding ligands' messenger ribonucleic acid (mRNA) gene expression were assessed in frozen adipose tissue by quantitative polymerase chain reaction (PCR). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16) | Baseline (Day 1) to Week 24 | Peripheral monocyte subsets (cluster of differentiation 14 (CD14/cluster of differentiation 16 (CD16)\] were measured in fresh peripheral blood mononuclear cells (PBMCs) samples by flow cytometry. Monocyte results are reported for Total, Classical (CD14+CD16-), Intermediate (CD14+CD16+) and Non-classical (CD14lowCD16+). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (Day1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Fasting Plasma Insulin (FPI) | Baseline (Day 1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of insulin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) | Baseline (Day1) to Weeks 12 and 24 | QUICKI is used to measure insulin sensitivity. QUICKI = 1/(log FPI μIU/mL + log FPG mg/dL). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR) | Baseline (Day 1) to Weeks 12 and 24 | HOMA-IR = (FPG mg/dL x FPI μIU/mL)/405. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B) | Baseline (Day 1) to Weeks 12 and 24 | HOMA-%B= (20 × FPI)/(FPG - 3.5). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c) | Baseline (Day 1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Plasma Glucagon Concentration | Baseline (Day 1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of glucagon. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load | Prior to Glucose Load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of glucose. |
| Secondary | Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load | Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of insulin. |
| Secondary | Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose | Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | AUC(0-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose | Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | AUC(30-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in AUC (0-120 Min) for Plasma Insulin | Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | AUC(0-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in AUC (30-120 Min) for Plasma Insulin | Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24 | AUC(30-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Fasting Free Fatty Acids | Baseline (Day 1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of free fatty acids. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
| Secondary | Change From Baseline in Serum Adiponectin Concentration | Baseline (Day1) to Weeks 12 and 24 | A fasting blood sample was collected and was sent to a central laboratory for analysis of adiponectin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. |
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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