Trial · NCT07891156
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in lean mass | Baseline to 24 weeks of study drug use | Change in total lean mass, measured in kilograms (kg). |
| Secondary | Fat mass (kilograms) | Baseline to 24 weeks | Change in total fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Proportion of lean mass to fat mass (percentage) | Baseline to 24 weeks | Change in the proportion of lean mass relative to fat mass as a percentage (%), measured using dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Bone density (grams per cubic centimetre) | Baseline to 24 weeks | Change in bone density measured in grams per cubic centimetre (g/cm³) using dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Appendicular lean mass and visceral fat mass (kilograms) | Baseline to 24 weeks | Change in appendicular lean mass and visceral fat mass measured in kilograms (kg) using dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Weight (kilograms) | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in body weight, measured in kilograms (kg), on an electronic scale. |
| Secondary | Hip circumference (centimetres) | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in hip circumference, measured in centimetres (cm). Use a measuring tape to measure the largest circumference around the buttock area. |
| Secondary | Waist circumference (centimetres) | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in waist circumference, measured in centimetres (cm) using anthropometric measurements. Use a measuring tape to measure at the level of the ischial crests as a landmark. |
| Secondary | Blood pressure (millimeters of mercury) | Baseline to 24 weeks | Change in blood pressure, measured in millimetres of mercury (mmHg), after a 5-minute reset, measured 3 times. We will average the 3 values. |
| Secondary | Mean peak torque | Baseline to 24 weeks | Change in mean peak torque during isokinetic and isometric knee extension/flexion, measured via Biodex. Results will be recorded as weight-based torque (Nm/kg). |
| Secondary | Handgrip strength test | Baseline to 24 weeks | Change in maximum handgrip strength for the dominant and non-dominant hands, measured in kilograms (kg) using a hand dynamometer. |
| Secondary | Six-minute walk test (distance in metre) | Baseline to 24 weeks | Change in the distance walked during the six-minute walk test (6MWT), measured in metres (m). |
| Secondary | General physical activity (steps/day) | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in average number of steps per day measured using an accelerometer. |
| Secondary | Time spent in different intensities of physical activity | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in time spent in light, moderate, and vigorous physical activity, measured in minutes per day using an accelerometer. |
| Secondary | Mean total energy consumed per day | Baseline to midpoint to 24 weeks | Change in mean total energy consumed per day, measured in kilocalories (kcals), using Keenoa. Keenoa - Food diary smartphone application |
| Secondary | Mean total carbohydrates/fat/protein | Baseline to midpoint (weeks 15-16) and 24 weeks | Change in mean daily intake of carbohydrates, fat, and protein, measured in grams per day (g/day) and as a proportion of energy, using Keenoa. Keenoa - Food diary smartphone application |
| Secondary | Three-factor eating questionnaire R-18 scores | Baseline to 24 weeks | Change in the Three-Factor Eating Questionnaire (TFEQ-R18) is an 18-item validated questionnaire regarding eating behaviour and restraint, including subscores of uncontrolled eating, cognitive restraint, and emotional eating. |
| Secondary | Canadian Food Intake Screener score | Baseline to 24 weeks | Change in the Canadian Food Intake Screener score (CFIS): a 16-item survey assessing healthy eating habits in relation to the Canadian Food Guide |
| Secondary | Modified Hypoglycemia Fear Survey II (mHFS-II). | Baseline to 24 weeks | A survey validated in type 1 diabetes to quantify fear of hypoglycemia based on a 5-point Likert scale, with higher scores associated with worsened fear of hypoglycemia. There are 2 subscales: i) HFS-Fear and ii) HFS-Behaviour. This has a total of 32 items. |
| Secondary | Diabetes Distress Scale (DDS). | Baseline to 24 weeks | A 17-item survey to quantify diabetes distress based on a 6-point Likert scale, with higher points associated with worsened diabetes distress. A mean item score of 2.0-2.9 signifies moderate distress, whereas a mean item score ≥ 3.0 signifies high distress. |
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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GET https://conductscience.org/api/trials/v1/NCT07891156/registered