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NCT Number: NCT06961682

Effectiveness of MD on MetS Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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]
  • 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)

Treatment and study plan

MD

Dietary Supplement

Red meats and sweets minimal consumption once or twice per month Eggs, cheese, poultry and yoghurt weekly consumption Fish and seafood two to three times per week Olive oil varing amount daily Vegetables and fruits daily consumption Legumes and whole grains (bread, pasta, rice and nuts )daily consumption Measure the effect of Mediterranean diet on patient with MetS to control hypertension, diabetes, obesity and dyslipidemia by measuring blood pressure mmHg regularly, Hba1c before, lipid profile LDL, HDL, TG weight (kg) and height (m) to calculate BMI wt kg/ht^2 m and waist hip ratio by measuring waist and hip circumference before and after the MD

Primary outcomes

  1. Assessment the effectiveness of MD on obese MetS patients

    Time frame: 6 months

    by measuring weight in kg and height in meters to calculate BMI which equal weight\\height square meters before and after MD at 3 and 6 months

  2. Assessment the effectiveness of MD on hypertensive MetS patients

    Time frame: 6 months

    by regular measuring to blood pressure mmHg before and after the MD

  3. Assessment the effectiveness of MD on diabetic MetS patients

    Time frame: 6 months

    by measuring Hga1c before and after the MD

  4. Assessment the effectiveness of MD on dyslipidemic MetS patients

    Time frame: 6 months

    by measuring lipid profile HDL, LDL, TG

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effectiveness of MD on Patient With MetS to Control Hypertension, Diabetes ,Obesity and Dyslipidemia in Patients Attending Assiut University Hospital

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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