GENETIC VARIABILITY TO GLP1 TREATMENT
GLP1 treatment
RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT
1 other identifier
interventional
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMarch 7, 2024
March 1, 2024
1.3 years
March 1, 2024
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Genetic variants and miRNA expressions associated with changes in A1c.
12 months
Other Outcomes (2)
Genetic variants and miRNA expressions associated with side effects.
12 months
Demographic parameters that affect GLP1 AG therapy.
12 months
Study Arms (1)
Collection of DNA/RNA samples
OTHERType 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GENGElead
Study Sites (1)
Rambem medical center
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
October 1, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
March 7, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share