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| Name | Class |
|---|---|
| LUX MED Group | OTHER |
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This study will assess the impact of genetic markers, microbiological (microbiome) and behavioral factors on tolerance, adherence and effectiveness of dual GLP1/GIP RA in the treatment of obesity.
200 consecutive patients who meet all inclusion and none of the exclusion criteria will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with BMI>27 | tirzepatide treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genetic polymorphism | Diagnostic Test | GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight change | weight change measured in kg and as BMI | 1 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| treatment discontinuation | number of patients who discontinue treatment prematurely | up to 6 months |
| adverse reactions | any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity |
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Inclusion criteria
Exclusion criteria
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Patients who are overweight or obese and were prescribed tirzepatide for their treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zbigniew Siudak PI, MD, PhD | Contact | +48 41 349 6972 | zbigniew.siudak@ujk.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waga Zmiany | Recruiting | Krakow | Poland |
We are willing to share data, however, due to the fact that data will come from different clinics and legal entities the form of IPD is to be established.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D011110 | Polymorphism, Genetic |
| D000069196 | Gastrointestinal Microbiome |
| ID | Term |
|---|---|
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D064307 | Microbiota |
| D008827 | Microbiological Phenomena |
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venous blood, stool samples and oral cavity swabs
| gut microbiome | Diagnostic Test | stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA |
|
| up to 6 months |
| Luxmed sp zoo | Recruiting | Warsaw | Poland |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D058448 |
| Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |