ObesityNCT06961682
Effectiveness of MD on MetS Patients
A study testing MD in people with Obesity, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- MD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
About this study
Official title: Effectiveness of MD on Patient With MetS to Control Hypertension, Diabetes ,Obesity and Dyslipidemia in Patients Attending Assiut University Hospital
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
- Being tested
- MD
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: MD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Assessment the effectiveness of MD on hypertensive MetS patients
by regular measuring to blood pressure mmHg before and after the MD
Measured: 6 months
Assessment the effectiveness of MD on diabetic MetS patients
by measuring Hga1c before and after the MD
Measured: 6 months
Assessment the effectiveness of MD on dyslipidemic MetS patients
by measuring lipid profile HDL, LDL, TG
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Gaber Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961682
- Sponsor's protocol ID
- Fam Med Dep AssiutU
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MD on Patient With MetS to Control Hypertension, Diabetes ,Obesity and Dyslipidemia in Patients Attending Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06961682
- Acronym / sponsor ID
- Fam Med Dep AssiutU
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome patients attending Assiut university hospital | Experimental | Dietary Supplement: MDMetS patients with diabetes, hypertension, dyslipidemia and obesity at least three criteria to diagnose the metabolic syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDRed 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 | Dietary supplement | Metabolic syndrome patients attending Assiut university hospital |
Primary outcome
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
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
Assessment the effectiveness of MD on diabetic MetS patients
Time frame: 6 months
by measuring Hga1c before and after the MD
Assessment the effectiveness of MD on dyslipidemic MetS patients
Time frame: 6 months
by measuring lipid profile HDL, LDL, TG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MD in people with Obesity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the effectiveness of MD on obese MetS patients (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.