Hesperidin and Diosmin Effect on Metabolic Syndrome

Study Overview
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Brief Summary
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The components of metabolic syndrome (MetS), particularly obesity and dyslipidemia, are linked to peripheral neuropathy (PN) among patients with diabetes or even without diabetes. Several studies revealed that complementary and herbal medicine could provide a potential for PN management and MetS components. Thus, designing clinical trials with interventions combinations to achieve a considerable improvement is highly recommended. Hesperidin and diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic, anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with high tolerability and safety profile

Official Title
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Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus

Conditions
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Metabolic Syndrome and Diabetic Neuropathy

Intervention / Treatment
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* Dietary Supplement: dietary supplement flavonoids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy Exclusion Criteria: patients without any parameter of inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hesperidin group<br> | Dietary Supplement: dietary supplement flavonoids<br>* patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention<br>|
| Active Comparator: Diosmin<br> | Dietary Supplement: dietary supplement flavonoids<br>* patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention<br>|
| Active Comparator: Hesperidin and diosmin<br> | Dietary Supplement: dietary supplement flavonoids<br>* patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome components | Waist circumference, (cm) | 12 weeks | 
| metabolic syndrome components | FBG, mg/dl | 12 weeks | 
| metabolic syndrome components | LDL, mg/dl | 12 weeks | 
| metabolic syndrome components | HDL | 12 weeks | 
| metabolic syndrome components | TGs, mg/dl | 12 weeks | 
| MNSI score for neuropathy | neuropathy improvement if MNSI score decreased | 12 weeks |