Metabolic Syndrome and Diabetic NeuropathyNCT05243238
Hesperidin and Diosmin Effect on Metabolic Syndrome
A study testing dietary supplement flavonoids in people with Metabolic Syndrome and Diabetic Neuropathy, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome and Diabetic Neuropathy
- What is being tested?
- dietary supplement flavonoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy
Who cannot join
- patients without any parameter of inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus
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
- Being tested
- dietary supplement flavonoids
- Medical subject headings
- Metabolic Syndrome, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement flavonoidsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Hesperidin group | Active comparator | Not described Receives: Dietary Supplement: dietary supplement flavonoids |
| Diosmin | Active comparator | Not described Receives: Dietary Supplement: dietary supplement flavonoids |
| Hesperidin and diosmin | Active comparator | Not described Receives: Dietary Supplement: dietary supplement flavonoids |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic syndrome components
Waist circumference, (cm)
Measured: 12 weeks
metabolic syndrome components
FBG, mg/dl
Measured: 12 weeks
metabolic syndrome components
LDL, mg/dl
Measured: 12 weeks
metabolic syndrome components
HDL
Measured: 12 weeks
metabolic syndrome components
TGs, mg/dl
Measured: 12 weeks
MNSI score for neuropathy
neuropathy improvement if MNSI score decreased
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Mar 2020
- Primary completion30 Nov 2020
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome and Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243238
- Sponsor's protocol ID
- FMBSU REC FWA#: FWA00015574
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35946912
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05243238
- Acronym / sponsor ID
- FMBSU REC FWA#: FWA00015574
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 17 Feb 2022 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hesperidin group | Active comparator | Dietary Supplement: dietary supplement flavonoids |
| Diosmin | Active comparator | Dietary Supplement: dietary supplement flavonoids |
| Hesperidin and diosmin | Active comparator | Dietary Supplement: dietary supplement flavonoids |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy
Key exclusion criteria (1 listed)
- patients without any parameter of inclusion criteria
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 |
|---|---|---|
| dietary supplement flavonoidspatients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention | Dietary supplement | Diosmin, Hesperidin and diosmin, Hesperidin group |
Primary outcome
metabolic syndrome components
Time frame: 12 weeks
Waist circumference, (cm)
metabolic syndrome components
Time frame: 12 weeks
FBG, mg/dl
metabolic syndrome components
Time frame: 12 weeks
LDL, mg/dl
metabolic syndrome components
Time frame: 12 weeks
HDL
metabolic syndrome components
Time frame: 12 weeks
TGs, mg/dl
MNSI score for neuropathy
Time frame: 12 weeks
neuropathy improvement if MNSI score decreased
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 35946912Osama 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement flavonoids in people with Metabolic Syndrome and Diabetic Neuropathy, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
metabolic syndrome components (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243238, which also lists 1 linked publication.
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 17 Feb 2022.