Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Standard of Care (Antidiabetic therapy advised as per physician discretion) + Sugar Fit Diabetes Reversal Management Program (SDRMP): Dose, route of administration, and frequency will
Duration of therapy: 3 Months. Visit1: Screening Visit 2: Baseline (Day 1) Visit 3: End of Study (EOS) (Day 90)
Sponsors
Ragus Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients with age group of above 18 years both men and women 2 Patients with history of diabetes with HbA1c greater than 7 with T2DM condition 3 Patients willing to sign an informed consent document 4 Patients who have not participated in any clinical study in the past 30 days
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis 2.Pregnant and lactating subjects 3.Patients with severe co-morbidities or disease conditions (Cardiac or Renal or Cancer) 4.End-stage renal disease or severe renal impairment (creatinine clearance more 30 ml per min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Improvement in HbA1c levels ?Improvement in FBS ?Improvement in weight, waist, and hip circumference Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Reduction in insulin resistance (HOMA IR C-peptide) ?Reduction in visceral fat adiposity (BCA) ?Improvement in Fatty liver index (LFT and USG abdomen if available) ?Measurement of sarcopenia using BCA and MUAC ?Inflammation Status (Blood CRP) ?Effect on Blood pressure ?Improvement in QRISK3 Score ?Improvement in DDS Score Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Punit Srivastava
Mediception Science Pvt Ltd
Outcome results
None listed