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Hesperidin and Diosmin Effect on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome and Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dietary supplement flavonoids
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome and Diabetic Neuropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Hesperidin group

Diosmin

Hesperidin and diosmin

control group

Arm Description

Outcomes

Primary Outcome Measures

metabolic syndrome components
Waist circumference, (cm)
metabolic syndrome components
FBG, mg/dl
metabolic syndrome components
LDL, mg/dl
metabolic syndrome components
HDL
metabolic syndrome components
TGs, mg/dl
MNSI score for neuropathy
neuropathy improvement if MNSI score decreased

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
February 14, 2022
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05243238
Brief Title
Hesperidin and Diosmin Effect on Metabolic Syndrome
Official Title
Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome and Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hesperidin group
Arm Type
Active Comparator
Arm Title
Diosmin
Arm Type
Active Comparator
Arm Title
Hesperidin and diosmin
Arm Type
Active Comparator
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement flavonoids
Intervention Description
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 Outcome Measure Information:
Title
metabolic syndrome components
Description
Waist circumference, (cm)
Time Frame
12 weeks
Title
metabolic syndrome components
Description
FBG, mg/dl
Time Frame
12 weeks
Title
metabolic syndrome components
Description
LDL, mg/dl
Time Frame
12 weeks
Title
metabolic syndrome components
Description
HDL
Time Frame
12 weeks
Title
metabolic syndrome components
Description
TGs, mg/dl
Time Frame
12 weeks
Title
MNSI score for neuropathy
Description
neuropathy improvement if MNSI score decreased
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University
City
Fayoum
ZIP/Postal Code
13556
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
35946912
Citation
Osama H, Hamed EO, Mahmoud MA, Abdelrahim MEA. The Effect of Hesperidin and Diosmin Individually or in Combination on Metabolic Profile and Neuropathy among Diabetic Patients with Metabolic Syndrome: A Randomized Controlled Trial. J Diet Suppl. 2023;20(5):749-762. doi: 10.1080/19390211.2022.2107138. Epub 2022 Aug 10.
Results Reference
derived

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Hesperidin and Diosmin Effect on Metabolic Syndrome

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