GENETIC VARIABILITY TO GLP1 TREATMENT
- Conditions
- ObesityType 2 Diabetes
- Interventions
- Genetic: DNA Sequencing and AnalysisGenetic: differential expression analysis with RNA-sequencing (RNA seq) experiments
- Registration Number
- NCT06298799
- Lead Sponsor
- GENGE
- Brief Summary
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:
* Informed consent
* Study eligibility (Inclusion / Exclusion criteria)
* Collection of demographic data (age (date of birth), gender, ethnic origin)
* General and T2DM medical history review (per subject file)
* Concomitant medication review (at enrollment)
* Physical attributes (Body Weight, Height, BMI)
* Allocation to study cohort and study subgroup
* Saliva and blood collection for genetic tests
* Self-reported questionnaire for Ozempic (Semaglutide) experience
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Diagnosed with type 2 diabetes (for participant in Cohort A) or Obese (for participant in Cohort B) and treated with Ozempic (Semaglutide) S.C. injection for at least 24 weeks.
- Subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment.
- Subject BMI above 30 kg/m2 at treatment initiation.
- Subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure.
- Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.
- Subject falls under contraindications to Ozempic (Semaglutide) label
- Subject known or suspected for hypersensitivity to any GLP-1RA or related products, or allergic constitution
- Subjects suffers from any other condition affecting body weight.
- Subject with history of chronic or acute pancreatitis
- Subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening.
- Presence or history of malignant neoplasm within 5 years prior to screening day.
- Subject suffers from any renal impairment (Cr > 2 mg/dl).
- Subject suffers from any impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit).
- Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
- Subject is a female who is pregnant, breastfeeding or intends to become pregnant or is of child bearing potential without medically acceptable methods of contraception.
- Participation in another clinical study in prior 4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Collection of DNA/RNA samples DNA Sequencing and Analysis Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples Collection of DNA/RNA samples differential expression analysis with RNA-sequencing (RNA seq) experiments Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples
- Primary Outcome Measures
Name Time Method Genetic variants and miRNA expressions associated with changes in BMI. 12 months Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in BMI.
- Secondary Outcome Measures
Name Time Method Genetic variants and miRNA expressions associated with changes in A1c. 12 months Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in A1c.
Trial Locations
- Locations (1)
Rambem medical center
🇮🇱Haifa, Israel