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OpenTrials
Completed

NCT Number: NCT05243238

Hesperidin and Diosmin Effect on Metabolic Syndrome

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

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Key information

Conditions

Metabolic Syndrome and Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University

Al Fayyum, 13556, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

dietary supplement flavonoids

Dietary Supplement

patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention

Primary outcomes

  1. metabolic syndrome components

    Time frame: 12 weeks

    Waist circumference, (cm)

  2. metabolic syndrome components

    Time frame: 12 weeks

    FBG, mg/dl

  3. metabolic syndrome components

    Time frame: 12 weeks

    LDL, mg/dl

  4. metabolic syndrome components

    Time frame: 12 weeks

    HDL

  5. metabolic syndrome components

    Time frame: 12 weeks

    TGs, mg/dl

  6. MNSI score for neuropathy

    Time frame: 12 weeks

    neuropathy improvement if MNSI score decreased

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2022

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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