Trial · NCT00645099
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Baseline to End Point (up to 6 months) | Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio. |
| Secondary | Change From Baseline to End Point in Triglycerides | Baseline to End Point (up to 6 months) | The TG level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in High Density Lipoprotein | Baseline to End Point (up to 6 months) | The HDL level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Total Cholesterol | Baseline to End Point (up to 6 months) | The total cholesterol level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Baseline to End Point (up to 6 months) | The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula. |
| Secondary | Change From Baseline to End Point in Converted Insulin | Baseline to End Point (up to 6 months) | The insulin level was assessed under fasted conditions. |
| Secondary | Change From Baseline to End Point in Fasting Glucose | Baseline to End Point (up to 6 months) | |
| Secondary | Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B) | Baseline to End Point (up to 6 months) | HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level). HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%. |
| Secondary | Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline to End Point (up to 6 months) | HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1. |
| Secondary | Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up | 6 months | Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study. |
| Secondary | Number of Patients With Onset of Impaired Glucose Tolerance | Baseline to End Point (up to 6 months) | Glucose ≥140 mg/dL, \<200 mg/dL after a 75g OGTT. |
| Secondary | Number of Patients With Impaired Fasting Glucose | Baseline to End Point (up to 6 months) | Post-baseline glucose level under fasted conditions ≥100 mg/dL but \<126 mg/dL. |
| Secondary | Change From Baseline at End Point of the Insulinogenic Index | Baseline to End Point (up to 6 months) | The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min \[G(30)\] - glucose at 0 \[G(0)\]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)\<0, the index was only calculated when G(30)\>G(0). |
| Secondary | Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin | Baseline to End Point (up to 6 months) | As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.). |
| Secondary | Change From Baseline at End Point in Body Weight | Baseline to End Point (up to 6 months) | Patients were weighed lightly clothed. The same amount of clothing had to be worn each time. |
| Secondary | Change From Baseline at End Point in Body Mass Index (BMI) | Baseline to End Point (up to 6 months) | BMI is calculated by dividing the body weight (in kg) by the square of height (in meters). |
| Secondary | Change From Baseline at End Point in Waist Circumference | Baseline to End Point (up to 6 months) | Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue. |
| Secondary | Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up | 6 months | Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met: * waist circumference men \> 102 cm; waist circumference women \> 88 cm * TG ≥ 150 mg/dL * HDL cholesterol men \<40 mg/dL; HDL cholesterol women \<50 mg/dL * Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg * Fasting glucose ≥ 110 mg /dL |
| Secondary | Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS) | Baseline to End Point (up to 6 months) | PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). |
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.
For software
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