Health Condition 1: null- People with Type 2 Diabetes between age 21-70 years
Conditions
Interventions
Intervention1: Very low carbohydrate ketogenic diet: Total dietary carbohydrates would be restricted to less than 30 g/day. Daily protein intake will be targeted to between 1.2 g/kg to 2.4 g/kg of lea
Sponsors
Novique Health Private LTD
Eligibility
Inclusion criteria
Inclusion criteria: All criteria must be mett: 1. People with type 2 diabetes 2. Age between 21-70 3. BMI > 24.99 4. HbA1c > 6.5% or HbA1c between 6-6.5% but still on one or more anti-diabetic medication or on any Oral hypoglycemic agents (other than metformin) irrespective of HbA1c
Exclusion criteria
Exclusion criteria: 1. Diagnosed underlying cardiac disease (Underlying arrhythmia/heart attack/heart failure, other) 2. Pregnancy or planned pregnancy 3. Past history/hospitalization for Ketoacidosis 4. Dietary fat intolerance 5. Renal dysfunction, as defined by Serum Creatinine >1.3 mg/dl 6. Hepatic Dysfunction as defined by SGOT/SGPT >100 IU/L 7. Mental health disorders 8. Cancer 9. Prior history of gallstones/active gallbladder disease 10. History of Pancreatitis 11. Poor nutritional status 12. History of Gout
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving glycemic control (HbA1c, BG) and Decreasing/eliminating anti-diabetic medications Timepoint: At start and end of 12 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreasing inflammation (CRP, WBC)Timepoint: At start and end of 12 weeks of intervention ;Enhancing Quality of Life of the study population as assessed by a) Hunger (1-4 scale) b) Mood (1-4 scale) c) Energy (1-4 scale) Timepoint: At start and end of 12 weeks of intervention ;Improving lipid profile (LDL, HDL, Triglycerides)Timepoint: At start and end of 12 weeks of intervention;Lowering Blood Pressure and reduction in the use of anti-hypertensive medicationTimepoint: At start and end of 12 weeks of intervention ;Lowering body weightTimepoint: At start and end of 12 weeks of intervention;Reducing economic impact of Type 2 diabetesTimepoint: At start and end of 12 weeks of intervention;Sustainability as indicated by drop-out ratesTimepoint: At start and end of 12 weeks of intervention | — |
Countries
India
Contacts
Public ContactRajiv Singla
Kalpavriksh Healthcare
Outcome results
None listed