RETRO-PROSPECTIVE OPEN STUDY TO ASSES GENETIC VARIABILITY AS A BASIS FOR PREDICTION OF THE RESPONSE TO GLP1 TREATMENT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Genetic variants and miRNA expressions associated with changes in BMI.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Collection of DNA/RNA samples
Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples
干预措施: DNA Sequencing and Analysis (Genetic)
Collection of DNA/RNA samples
Type 2 Diabetic participants cohort or Healthy participants cohort who will perform Collection of DNA/RNA samples
干预措施: differential expression analysis with RNA-sequencing (RNA seq) experiments (Genetic)
结局指标
主要结局
Genetic variants and miRNA expressions associated with changes in BMI.
时间窗: 12 months
Identify genetic variants and miRNA expressions that affects the response to GLP-1 treatment associated with changes in BMI.
次要结局
- Genetic variants and miRNA expressions associated with changes in A1c.(12 months)