Impact of diet plus exercise on endothelial function, arterial stiffness and blood pressure in stage 1 hypertensive patients: results from the ?INTreat randomized, open-label trial
Not Applicable
- Conditions
- Hypertension.Essential (primary) hypertension
- Registration Number
- IRCT20200307046715N1
- Lead Sponsor
- Mitropoleos 92 St
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
Untreated stage 1 hypertensive
Adults
Agreed to participate
Exclusion Criteria
Diagnosis of secondary hypertension
Diabetes Mellitus
Cardiovascular Diseases
Any known inflammatory condition
Malignancy
Other significant comorbidities affecting blood pressure
Treatment with anti hypertensive agents or other significant medication including diuretics
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure. Timepoint: baseline, 3 months, 6 months. Method of measurement: sphygmomanometer.;Carotid intima-media thickness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Carotid stiffness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Pulse wave velocity. Timepoint: baseline, 6 months. Method of measurement: ABPM, Mobil-O-Graph.;Lipid profile (Total Cholesterol, TG, HDL, LDL). Timepoint: baseline, 6 months. Method of measurement: Fasting blood sample.
- Secondary Outcome Measures
Name Time Method Anthropometry changes (body weight, waist & hip circumference, body synthesis). Timepoint: baseline, 6 months. For body weight and circumferences also at 3 months. Method of measurement: weight scale, measuring tape, bioelectrical impedance.;Physical activity level. Timepoint: baseline, 6 months. Method of measurement: IPAQ, pedometer.;Diet changes. Timepoint: baseline, 6 months. 24 hour recall used at 3 months. Method of measurement: (3day recall, 24hour recall, MedDiet score, DII score, salt score).;Urinary losses in sodium, potassium, creatinine, microalbumin. Timepoint: baseline, 3 & 6 months. Method of measurement: 24h urinary sample analysis.;Resting energy expenditure. Timepoint: baseline, 6 months. Method of measurement: Indirect calorimetry (Breezing).