Effectiveness of MD on MetS Patients

NCT06961682 | Not Yet Recruiting

• 1 other identifier: Fam Med Dep AssiutU
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• Assessment the effectiveness of MD on obese MetS patients

  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

  6 months

• Assessment the effectiveness of MD on hypertensive MetS patients

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

  6 months

• Assessment the effectiveness of MD on diabetic MetS patients

  by measuring Hga1c before and after the MD

  6 months

• Assessment the effectiveness of MD on dyslipidemic MetS patients

  by measuring lipid profile HDL, LDL, TG

  6 months

Study Arms (1)

Metabolic syndrome patients attending Assiut university hospital

EXPERIMENTAL

MetS patients with diabetes, hypertension, dyslipidemia and obesity at least three criteria to diagnose the metabolic syndrome

Dietary Supplement: MD

Interventions

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

Metabolic syndrome patients attending Assiut university hospital

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[12\]

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share