Trial · NCT07120815
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Weight will be measured by a standard scale to an accuracy of +/- 0,1kg. |
| Primary | Homeostatic model assessment for insulin resistance (HOMA-IR) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | HOMA-IR will be calculated with the formula: fasting plasma glucose (mmol/L) × fasting serum insulin (mU/L) divided by 22.5 (9) |
| Primary | Hirsutism | The investigators will report change from baseline to 14 and 26 weeks. | Modified Ferriman Gallwey score (mFG) will be measured and a score of 4 or more will be regarded as hirsutism in Caucasian women, whereas a score of 6 or more will be regarded hirsutism for other ethnicities |
| Primary | Total testosterone | The investigators will measure change from baseline to 14 and 26 weeks | Testosterone nmol/l (liquid chromatography with tandem mass spectrometry (LC-MS/MS). All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Primary | Appearance of severe of adverse effects | The investigators will measure change from baseline to 14 and 26 weeks | In our questionnaire the investigators will ask the participants whether they have experienced abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks and grade the symptoms from 1-5 (1 being never and 5 being all the time). The investigators will count the scores and give each participant a score between 5-25. A severe adverse effect is defined as a score of 4 or more in one of the questions (indicating a daily experience of abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks). |
| Primary | Anti-Mullerian hormone (AMH) | The investigators will measure change from baseline to 14 and 26 weeks | AMH will be measured in ug/l. All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | Body mass index (BMI) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Weight (kilogram) and height (metre) will be combined to report BMI in kg/m\^2 |
| Secondary | Waist circumference (WC) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | WC will be measured halfway between the participant's lowest rib and the top of the participant's hipbone |
| Secondary | Waist-hip-ratio (WHR) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | WHR will be calculated as waist measurement divided by hip measurement (W⁄H). Hip circumference is determined as the maximum value over the glottal region, measured to the nearest centimetre. |
| Secondary | Body adiposity index (BAI) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | BAI will be measured using the following equation: hip circumference (cm)/height (m) - 18 |
| Secondary | Body composition | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Body composition will be measured with a multi-frequency segmental body composition analyzer (TANITA Health Ware) WHR (Waist-hip-ratio). Will be calculated as waist measurement divided by hip measurement (W⁄H). Hip circumference is determined as the maximum value over the glottal region, measured to the nearest centimetre. WC (Waist circumference). Measured halfway between the participant's lowest rib and the top of the participant's hipbone BAI (Body adiposity index). Will be measured using the following equation: hip circumference (cm)/height (m) - 18 BP (blood pressure) (systolic and diastolic) and pulse. Will be measured twice with at least 3 minutes apart after at least 10 min rest from non-dominant upper extremity in a subject in supine position |
| Secondary | Blood pressure (BP) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | BP (systolic and diastolic) will be measured twice with at least 3 minutes apart after at least 10 min rest from non-dominant upper extremity in a subject in supine position |
| Secondary | Pulse | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Pulse will be measured twice with at least 3 minutes apart after at least 10 min rest from non-dominant upper extremity in a subject in supine position |
| Secondary | Fasting glucose | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | fasting glucose mmol/l (photometric hexokinase method) All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | Fasting insulin | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | fasting insulin mU/l (immunochemiluminometric assay) All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | HbA1C | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | HbA1C mmol/mol (photometric enzymatic method) All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | Lipids (cholesterol and its subclasses, triglycerides) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Total cholesterol, mmol/l and triglycerides mmol/l with an enzymatic photometric method, LDL and HDL mmol/l with a direct enzymatic photometric method All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | C-reactive protein (CRP) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | CRP will be measured in mg/l (photometric immunochemical method) All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | 2-hour oral glucose tolerance test (OGTT) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | 2-hour OGTT mmol/l |
| Secondary | Alanine Aminotransferase (ALAT) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | ALAT will be measured in U/l (photometric method according to the International Federation of Clinical Chemistry and Laboratory Medicine recommendation) All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07120815/registered