Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 70 years. 2.Diagnosed with Type 2 Diabetes Mellitus (T2DM) for less than two years. 3.HbA1c below 10%. 4.BMI between 25 and 40 kg/m .
Exclusion criteria
Exclusion criteria: 1.Type 1 Diabetes or other forms of diabetes. 2.Previous use of GLP-1 receptor agonists or SGLT-2 inhibitors (within last 3-months). 3.History of pancreatitis or severe gastrointestinal disorders. 4.Planning Pregnancy or Pregnant or breastfeeding. 5.Significant renal impairment (eGFR below 60 mL/min/1.73 m ) and hepatic impairment. 6.Patient suffering from any chronic infection like tuberculosis, hepatitis B and C. 7.Patient suffering from any malignancy. 8.Patients with personal or family history of medullary thyroid carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of T2DM participants achieving remission(HbA1c below 6.5%)post-withdrawal of combination-therapy(oral semaglutide+dapagliflozin+metformin) along with medical nutrition-therapyTimepoint: Assessment over the period of three years | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of lifestyle-modifications in achieving T2DM remission, with a liquid to semisolid-diet followed by gradual introduction of solid-diet and regular moderate exercise along-with metformin.Timepoint: Assessment over the period of three years;To compare the efficacy, and sustainability of remission between combination-pharmacotherapy and lifestyle-interventions.Timepoint: Assessment over the period of three years | — |
Countries
India
Contacts
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh