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
About this trial
This is an interventional treatment trial for Metabolic Syndrome and Diabetic Neuropathy
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
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
NCT ID
NCT05243238
First Posted
February 3, 2022
Last Updated
February 14, 2022
Sponsor
Beni-Suef University
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
Learn more about this trial
Hesperidin and Diosmin Effect on Metabolic Syndrome
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