Type 2 DiabetesGLP1 treatmentNCT06298799
GENETIC VARIABILITY TO GLP1 TREATMENT
A study testing DNA Sequencing and Analysis and differential expression analysis with RNA-sequencing (RNA seq) experiments in people with Type 2 Diabetes and Obesity, run by GENGE at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- DNA Sequencing and Analysis and differential expression analysis with RNA-sequencing (RNA seq) experiments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Ilana Reznikov contact
Israel1 site, 1 recruiting
- Recruiting
Rambem medical center
Haifa
Irit Hochberg, MD
About this study
Official title: RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT
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
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- DNA Sequencing and Analysis, differential expression analysis with RNA-sequencing (RNA seq) experiments
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Sequencing and AnalysisGenetic
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.
differential expression analysis with RNA-sequencing (RNA seq) experimentsGenetic
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
| Study group | Role | What they receive |
|---|---|---|
| Collection of DNA/RNA samples | Other | Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples Receives: Genetic: DNA Sequencing and Analysis; Genetic: differential expression analysis with RNA-sequencing (RNA seq) experiments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study population consists of two cohorts: A. Type 2 Diabetic participants cohort B. Healthy participants cohort
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GENGE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298799
- Sponsor's protocol ID
- GEN-GE-001-IL
- Acronym
- GLP1 treatment
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT
- ClinicalTrials.gov ID
- NCT06298799
- Acronym / sponsor ID
- GLP1 treatment / GEN-GE-001-IL
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GENGEUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population consists of two cohorts: A. Type 2 Diabetic participants cohort B. Healthy participants cohort
| Arm | Type | Receives |
|---|---|---|
| Collection of DNA/RNA samples | Other | Genetic: DNA Sequencing and Analysis, Genetic: differential expression analysis with RNA-sequencing (RNA seq) experimentsType 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA Sequencing and AnalysisDNA 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. | Genetic | Collection of DNA/RNA samples |
| differential expression analysis with RNA-sequencing (RNA seq) experimentsPerforming 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 | Genetic | Collection of DNA/RNA samples |
Primary outcome
Genetic variants and miRNA expressions associated with changes in BMI.
Time frame: 12 months
Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in BMI.
1 secondary outcome
Genetic variants and miRNA expressions associated with changes in A1c.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Reznikov contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA Sequencing and Analysis and differential expression analysis with RNA-sequencing (RNA seq) experiments in people with Type 2 Diabetes and Obesity, run by GENGE at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hila Kfir (+972-523313350, hilaz28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variants and miRNA expressions associated with changes in BMI. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.