Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Twin Precision nutrition along with standard of care
medications for hypertension
: Patients randomized to the intervention group will follow the medicine, exercise, sleep and
nutrition
Sponsors
Twin Health
Eligibility
Inclusion criteria
Inclusion criteria: On treatment for hypertension (monotherapy or multiple drugs)
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension ( > 180/110 mm of Hg) or history of hypertensive emergency requiring admission 2. Hypertension due to secondary causes 3. Diabetes mellitus 4. Heart failure with EF 5. eGFR less than 60 ml/min/1.73 m2 6. Any major cardiovascular event in the last 12 months (such as MI, stroke, TIA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in blood pressure as measured by ambulatory blood pressure monitoring at the end of 3 months 2. Change in blood pressure as measured in the clinic at the end of 3 months.Timepoint: 1. Change in blood pressure as measured by ambulatory blood pressure monitoring at the end of 3 months 2. Change in blood pressure as measured in the clinic at the end of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood pressure as measured by ambulatory blood pressure at 6 months and 1 year. (Clinical and ambulatory blood pressure)Timepoint: 6 months and 1 year;Change in metabolic parameters. Will include anthropometric assessment (Height, Weight, BMI, waist circumference, visceral fat), lipid profile lipoprotein (a), apolipoprotein - A1, apolipoprotein - B, insulin resistance (measured by fasting blood sugar and insulin level), thyroid profile, testosteroneTimepoint: 3 months, 6 months and 1 year;Change inInflammatory markers Complete blood count with ESR, hsCRP, uric acidTimepoint: 3 months, 6 months and 1 year;Exploratory biomarkers: Markers of endothelial function (Endothelin, VCAM) and antioxidant stress biomarkers (cortisol, malondialdehyde, nitric oxide and glutathione).Timepoint: 3 months, 6 months and 12 months;Ferritin, vitamin B12, folic acid, other vitamins and minerals, electrolytes, testosterone and estradiol.Timepoint: 3 months, 6 months and 12 months;Hypertension mediated organ damage (Brain, cardiac, kidney and eye) assessment â?? Cardiac parameters â?? Eye assessment Fundus examination â?? Neurological assessment Cognitive assessment using Montreal Cognitive assessment (in patients 60 years and above) â?? Renal assessmentTimepoint: Blood investifations:3 months, 6 months and 1 year Cognitive assessment and retinopathy: 1 year cIMT, Echo: 3,6 and 12 months;Improvement in quality of life using SF-36.Timepoint: 3 months, 6 months and 12 months;Major adverse Cardiac outcomes such as occurrence of MI, stroke.Timepoint: 12 months and 24 months;Requirement of antihypertensive medications (at 3 months, 6 months and 1 year) Antihypertensive medicines will be slowly tapered once target blood pressure is achieved.Timepoint: 3 months, 6 months and 1 year;Safety outcomes will include all reported adverse effects, abnormal changes in blood investigations, frequency of uncontrolled hypertension, hospital admissions due to uncontrolled blo | — |
Countries
India
Contacts
Public ContactDr Paramesh Shamanna
Bangalore Diabetes Centre
Outcome results
None listed