Clinical trial NCT06961682: Effectiveness of MD on MetS Patients
Official title: Effectiveness of MD on Patient With MetS to Control Hypertension, Diabetes ,Obesity and Dyslipidemia in Patients Attending Assiut University Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The metabolic syndrome (MetS), is a complicated condition linked to coronary artery disease.This group includes visceral obesity (abdominal or android type obesity), insulin resistance (IR), hypertension, and dyslipidaemia.The global prevalence of MetS is estimated to be about one-quarter of the world population or over a billion global citizens .A high MetS prevalence of 55% was found in Egyptians, 85.6% among diabetics, and 76.6% among hypertensive patients .People can modify their diet, physical activity, decrease smoking habits to lower their chance of developing MetS. Frequent exercise can lower blood pressure while increasing insulin sensitivity, lipolysis, and energy expenditure. It has the ability to improve blood lipid parameters .Diet is one of the most important tools available to improve MetS. However, the diet for the prevention and treatment of MetS remains unspecified beyond weight control and reduction in total calories. Several evidences show that it should generally be low in saturated fats, trans fats, cholesterol, sodium and simple sugars .The adherence to the Mediterranean Diet(MD) brings up two positive features, firstly the activity levels are increased and secondly the environmental impact becomes self-rewarding. The more the MD is favoured, the more the self-productivity is achieved resulting in a stronger life style adaptation .MD causes reduction of CVD incidence and outcomes decreases BP (systolic and diastolic) , inverses association with mortality,improvements in dyslexia, decreases incidence of T2DM.


Eligibility criteria: 1. Inclusion criteria:

   All people diagnosed as metabolic syndrome
   * (Hypertension(systolic BP≥130 or Diastolic BP ≥85)
   * prediabetes fasting plasma glucose(100-125),oral glucose tolerance test(140-199)Hba1c(5.7-6.4)ADA
   * Diabetes, fasting\>125, oral glucose tolerance test\>200, Hba1c≥6.5 ADA .
   * Hyperlipidaemia(TG≥150 mg\\dl-HDL\<40 in male and \<50 in female) \[12\]
   * Obesity(waist circumference ≥102cm in male and ≥88cm in female) \[12\]
2. Exclusion criteria:

   * Type 1 diabetes
   * Patients with renal or advanced liver disease(Failure)
   * Oral contraceptives, psychiatric, neurologic medications and steroid therapy
   * Patients with heart failure and presence of stent
   * Endocrine disease (Thyroid disease especially hypothyroidism-Cushing disease)

Primary outcomes:
measure: Assessment the effectiveness of MD on obese MetS patients
timeFrame: 6 months
measure: Assessment the effectiveness of MD on hypertensive MetS patients
timeFrame: 6 months
measure: Assessment the effectiveness of MD on diabetic MetS patients
timeFrame: 6 months
measure: Assessment the effectiveness of MD on dyslipidemic MetS patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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