Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Males and females aged 18 to 80 years. 2.Body Mass Index (BMI) equal to or greater than 30 kilograms per square meter. 3.Waist circumference equal to or greater than 102 cm for males and equal to or greater than 88 cm for females. 4.Willingness to participate in a weight loss program. 5.Stable weight within plus or minus five percent for at least 3 months prior to screening. 6.Subjects with obesity and T2DM who are currently being treated with anti-obesity/anti-diabetic drug or planning to receive. 7.Subjects planning to receive anti-obesity/anti-diabetic drug for minimum period of 6 months unless there is no response or having unacceptable toxicity. 8.Subjects who are able to understand and willing to sign the informed consent form (ICF). 9.Subjects who are willing and able to comply with scheduled visit.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Age less than 18 years and more than 80 years. 2.History of bariatric surgery or planning to undergo bariatric surgery during the study. 3.Subjects with severe/life threatening comorbidities 4.Subjects in active malignancy receiving anticancer treatment. 5.Pregnancy, lactation, or planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Determine the longitudinal changes in gene signatures of stem cell enriched population and PBMC in response to anti-obesity drugs. 2.Determine the alterations at protein levels and correlate with gene expressions. 3.Transcriptional profile will help in understanding the dynamic changes in the gene expression at different time points and determine the personalized drug response. 4.Pharmacogenomic profile will provide genotype-based drug choice and the stratification of potential responders from non-responders.Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Epigeneres Biotech Private Limited