Trial · NCT07332273
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in body weight (kg) from baseline to Month 3 | Baseline to Month 3 (12 weeks ±2) | |
| Primary | Change in fat mass (kg) by bioimpedance from baseline to Month 3 | Baseline to Month 3 (12 weeks ±2) | |
| Secondary | Weight-regain (kg) from Month 3 to Month 9 | Month 3 to Month 9 (36 weeks ±2) | |
| Secondary | Change in BMI (kg/m²) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in waist circumference (cm) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in fasting LDL-cholesterol (mg/dL) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in glycaemic control (HbA1c, %) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in insulin resistance (HOMA-IR) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in resting energy expenditure (kcal/day) by indirect calorimetry from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in physical activity level measured by accelerometry | Baseline to Month 9 | Physical activity will be quantified by accelerometry using the ActiGraph WGT3X-BT device, worn for 7 consecutive days before and after the intervention periods, as specified in the protocol. |
| Secondary | Change in blood pressure parameters assessed by ambulatory blood pressure monitoring (ABPM) from baseline to Month 9 | Baseline to Month 9 | Ambulatory blood pressure monitoring (24-hour ABPM) will be performed to register possible blood pressure adverse events, as specified in the protocol. |
| Secondary | Change in heart rate measured by electrocardiogram (ECG) from baseline to Month 9 | Baseline to Month 9 | Cardiac evaluation will be performed by electrocardiogram (ECG). Minimum, maximum and average heart rates will be assessed as specified in the protocol. |
| Secondary | Change in number of ventricular extrasystoles measured by electrocardiogram (ECG) from baseline to Month 9 | Baseline to Month 9 | The number of ventricular extrasystoles will be assessed by electrocardiogram (ECG) during cardiac evaluation, according to the protocol. |
| Secondary | Change in QT interval measured by electrocardiogram (ECG) from baseline to Month 9 | Baseline to Month 9 | QT interval will be evaluated by electrocardiogram (ECG) as part of the cardiac assessment described in the protocol. |
| Secondary | Incidence of adverse events (AEs) and serious adverse events (SAEs) | From first dose to Month 9 | |
| Secondary | Change in quality of life measured by EuroQol-5D index from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in quality of life measured by EuroQol-5D visual analogue scale (VAS) from baseline to Month 9 | Baseline to Month 9 | |
| Secondary | Change in gene expression related to metabolic activity in adipose tissue (subsample) | Baseline to Month 3 | Gene expression changes in adipose tissue samples related to lipogenic and lipolytic capacity, adipokines, thyroid receptor and browning biomarkers will be analyzed, as described in the protocol. |
| Secondary | Change in protein abundance related to metabolic activity in adipose tissue (subsample) | Baseline to Month 3 | Protein abundance changes in adipose tissue samples related to metabolic activity will be evaluated according to the protocol. |
| Secondary | Change in mitochondrial DNA in adipose tissue (subsample) | Baseline to Month 3 | Mitochondrial DNA in adipose tissue samples will be analyzed as part of the metabolic activity assessment described in the protocol. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07332273/registered