RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Israel
Rambem medical center
RECRUITING
Haifa
Contact Information
Primary
Hila Kfir
hilaz28@gmail.com
+972-523313350
Backup
Ilana Reznikov
Reznikovilana@gmail.com
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 400
Treatments
Other: Collection of DNA/RNA samples
Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples
Related Therapeutic Areas
Sponsors
Leads: GENGE

This content was sourced from clinicaltrials.gov