Trial · NCT03574597
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 29 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 0, week 104 | Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 0, week 104 | Change in LDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Triglycerides - Ratio to Baseline | Week 0, week 104 | Change in triglycerides (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Body Weight | Week 0, week 104 | Percentage change in body weight from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in Waist Circumference | Week 0, week 104 | Change is waist circumference from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104 | Week 0, week 104 | EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. Index score records an average health status according to dimensions using an algorithm, ranges 0-1 with higher score indicates better health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death). |
| Secondary | Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104 | Week 0, week 104 | EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. VAS component records a participant's overall self-rated health on a range of 0-100 with higher score indicates better self-reported health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death). |
| Secondary | Change in HbA1c - Percentage | Week 0, week 104 | Change in HbA1c (percentage) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Secondary | Change in HbA1c - mmol/Mol | Week 0, week 104 | Change in HbA1c (mmol/mol) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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GET https://conductscience.org/api/trials/v1/NCT03574597/registered?page=2