Trial · NCT05716607
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 | glycemic variability | 4 weeks | glycemic variability |
| Secondary | HbA1c | 4 weeks | HbA1c |
| Secondary | Time in range (glucose) | 4 weeks | Time in range (glucose) |
| Secondary | Time above range (glucose) | 4 weeks | Time above range (glucose) |
| Secondary | Time below range (glucose) | 4 weeks | Time below range (glucose) |
| Secondary | Cortisol exposure-time profile | 4 weeks | Cortisol exposure-time profile |
| Secondary | systolic blood pressure | 4 weeks | systolic blood pressure in sitting position |
| Secondary | diastolic blood pressure | 4 weeks | diastolic blood pressure in sitting position |
| Secondary | ADDIQoL | 4 weeks | questionnaire: the Addison-specific quality-of-life (ADDIQoL) The AddiQoL is a 36-item questionnaire; each item contains six scoring categories. Twenty-five items are negative Health-Related Quality of Life (HRQoL) statements that need to be reversed for questionnaire scoring; thus, a higher score indicates a higher level of HRQoL. |
| Secondary | PGWB | 4 weeks | questionnaire: the Psychological General Well-Being (PGWB) index The Psychological General Well-Being Index (PGWBI) is a measure of the level of subjective psychological well-being. In detail, it assesses self-representations of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress and thus captures what we could call a subjective perception of well-being. Consisting of 22 standardized items (6 items for the short form), the tool produces a single measure of psychological well-being. The full measure also provides sub-scales to assess the following domains: anxiety, depression, positive well-being, self-control, general health, and vitality. |
| Secondary | FIS | 4 weeks | questionnaire: the Fatigue Impact Scale (FIS) The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning minimum and maximum values, and whether higher scores mean a better or worse outcome. Higher scores mean a worse outcome. Min 0 points, max 160 points. |
| Secondary | FOSQ | 4 weeks | questionnaire: the Functional Outcomes of Sleep Questionnaire (FOSQ) Disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. Name of categories assessed: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). Higher scores mean a better outcome. Min 0 points, max 120 points. |
| Secondary | Fever | 4 weeks | Incidence of infections with high fever (patients judgement) |
| Secondary | CD16 | 4 weeks | immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16 |
| Secondary | ADAM17 | 4 weeks | immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17 |
| Secondary | transcriptomics | 4 weeks | RNA sequencing for large-scale study of gene expression in circulation |
| Secondary | microRNAs | 4 weeks | large-scale study of microRNAs in circulation |
| Secondary | proteomics | 4 weeks | large-scale study of proteomes (proteins produced in study subjects) |
| Secondary | metabolomics | 4 weeks | large-scale study of metabolome (metabolites produced in study subjects) |
| Secondary | hsCRP fibrinogen, immunoglobulin | 4 weeks | High-sensitivity C-reactive Protein (laboratory measurement) |
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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