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The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.
Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collection of DNA/RNA samples | Other | Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA Sequencing and Analysis | Genetic | DNA extracted from saliva / oral mucosa will be tested for diversities reported in the literature known to be associated with T2DM and Obesity and which may have a potential impact on the response to treatment with Semaglutide. In addition, the DNA will be screened for new diversities that have a potential impact on the response to treatment. working assumption of the study is that there can be 3 types of genetic variants that affect the drug's effectiveness and/or side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variants and miRNA expressions associated with changes in BMI. | Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in BMI. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variants and miRNA expressions associated with changes in A1c. | Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in A1c. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variants and miRNA expressions associated with side effects. | Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with side effects. | 12 months |
| Demographic parameters that affect GLP1 AG therapy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hila Kfir | Contact | +972-523313350 | hilaz28@gmail.com | |
| Ilana Reznikov | Contact | Reznikovilana@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambem medical center | Recruiting | Haifa | Israel |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017422 | Sequence Analysis, DNA |
| D001483 | Base Sequence |
| ID | Term |
|---|---|
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D015394 | Molecular Structure |
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The study population consists of two cohorts:
A. Type 2 Diabetic participants cohort B. Healthy participants cohort
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no masking
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|
| differential expression analysis with RNA-sequencing (RNA seq) experiments | Genetic | Performing small RNA sequencing experiments on an Illumina Next-Generation Sequencing (NGS) machine to investigate microRNAs (miRNAs) or other small non-coding RNAs involves specific steps tailored to the unique characteristics of these molecules |
|
To identify demographic parameters that affect the response to GLP1 AG therapy.
| 12 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001669 |
| Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |