Trial · NCT07904962
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | Glycated Hemoglobin (HbA1c) will be measured from a venous blood sample and reported as a percentage (%). The primary comparison will evaluate HbA1c at Week 12 between the randomized groups, with baseline HbA1c accounted for in the primary statistical analysis. |
| Secondary | Fasting Plasma Glucose at Week 12 | Week 12 | Fasting plasma glucose will be measured from a venous blood sample after an overnight fast and reported in mmol/L. |
| Secondary | 2-Hour Plasma Glucose During the Oral Glucose Tolerance Test at Week 12 | Week 12 | Plasma glucose will be measured 120 minutes after ingestion of a 75-g oral glucose load and reported in mmol/L. |
| Secondary | Normal Glucose Regulation at Week 12 | Week 12 | Normal glucose regulation will be defined as meeting all of the following criteria at Week 12: fasting plasma glucose \<5.6 mmol/L, 2-hour plasma glucose \<7.8 mmol/L during a 75-g oral glucose tolerance test, and glycated hemoglobin (HbA1c) \<5.7%. The outcome will be reported as the number and proportion of participants meeting these criteria. |
| Secondary | Total Body Fat Percentage at Week 12 | Week 12 | Total body fat percentage will be assessed using dual-energy X-ray absorptiometry (DXA) and reported as a percentage (%). |
| Secondary | Short Physical Performance Battery Total Score at Week 12 | Week 12 | Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes standing balance, usual 4-meter walking speed, and five repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance. |
| Other | Matsuda Insulin Sensitivity Index at Week 12 | Week 12 | The Matsuda insulin sensitivity index will be calculated from glucose and insulin concentrations measured during the 75-g oral glucose tolerance test at 0, 30, 60, 90, and 120 minutes. Higher values indicate greater insulin sensitivity. |
| Other | Glucose Coefficient of Variation From Continuous Glucose Monitoring at Week 12 | 14-day monitoring period at Week 12 | Glucose variability will be assessed using the coefficient of variation derived from continuous glucose monitoring data. Continuous glucose monitoring will be conducted in a prespecified exploratory subgroup. |
| Other | Moderate-to-Vigorous Physical Activity at Week 12 | 7-day monitoring period at Week 12 | Moderate-to-vigorous physical activity will be assessed objectively using an ActiGraph GT3X accelerometer and summarized as average minutes per day during valid wear days. |
| Other | Knee Extensor Peak Torque at Week 12 | Week 12 | Knee extensor strength will be assessed using isokinetic dynamometry at 60°/s. Peak torque will be recorded in N·m, with bilateral measurements obtained according to the standardized testing protocol. |
| Other | 6-Minute Walk Distance at Week 12 | Week 12 | Functional exercise capacity will be assessed using the 6-minute walk test. The primary measure will be the total distance walked in 6 minutes, reported in meters. |
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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