Clinical trial NCT06298799: GENETIC VARIABILITY TO GLP1 TREATMENT
Official title: RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: GENGE
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study population consists of two cohorts:

A. Type 2 Diabetic participants cohort B. Healthy participants cohort
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment.
3. Subject BMI above 30 kg/m2 at treatment initiation.
4. Subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure.
5. Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.

Exclusion Criteria:

1. Subject falls under contraindications to Ozempic (Semaglutide) label
2. Subject known or suspected for hypersensitivity to any GLP-1RA or related products, or allergic constitution
3. Subjects suffers from any other condition affecting body weight.
4. Subject with history of chronic or acute pancreatitis
5. Subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening.
6. Presence or history of malignant neoplasm within 5 years prior to screening day.
7. Subject suffers from any renal impairment (Cr \> 2 mg/dl).
8. Subject suffers from any impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit).
9. Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
10. 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.
11. Participation in another clinical study in prior 4 weeks.

Primary outcomes:
measure: Genetic variants and miRNA expressions associated with changes in BMI.
timeFrame: 12 months
Secondary outcomes:
measure: Genetic variants and miRNA expressions associated with changes in A1c.
timeFrame: 12 months
Other outcomes:
measure: Genetic variants and miRNA expressions associated with side effects.
timeFrame: 12 months
measure: Demographic parameters that affect GLP1 AG therapy.
timeFrame: 12 months
Locations:
city: Haifa
country: Israel
facility: Rambem medical center
Study officials:
References: