Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Sabesh S
Eligibility
Inclusion criteria
Inclusion criteria: Ability to provide written informed consent, BMI greater than or equal to 25 kg per m²,Diagnosed T2DM (HbA1c greter than 7 percentage), eGFRcr between 30 and 90 ml per min per 1.73 m² body surface area, Planned initiation of tirzepatide therapy based on clinical decision
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus, Pregnancy or lactation, Severe GI disorders or malabsorption, Acute Kidney Injury, Severe hepatic impairment, Current diagnosis of any malignancy, Subject who participated in any other clinical investigation using an experimental drug in the past 3 months, Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in eGFRcys:eGFRcr ratio, Mean change in body weightTimepoint: Outcomes will be assessed at baseline (before starting Tirzepatide), 4 weeks, 8 weeks , and 12 weeks after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, especially gastrointestinal (GI) side effects, Mean change in Diabetes-Specific Quality of Life Scale (DSQOLS) scores for diabetes Mean change in Patient Reported Outcomes in Obesity (PROS) questionnaire scores Correlation between socioeconomic status and changes in quality-of-life scoresTimepoint: From baseline to Week 12 | — |
Countries
India
Contacts
Public ContactSabesh S
SRM College of Pharmacy, SRM IST
Outcome results
None listed