DMPhase 3NCT03925714
Impact of P53 and SIRT1 in Type 2 Diabetes
A Phase 3 study testing life style, Metformin and Nigetella salivata in people with DM, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Investigating the impact of p53 and SIRT1 in the development of type 2 DM Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DM
- What is being tested?
- life style, Metformin and Nigetella salivata
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetic subjects.
Who cannot join
- Confirmed diabetes.
- Hepatic or renal impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Investigating the Impact of p53 and SIRT1 in the Development of Type 2 DM Through the Treatment of Prediabetic Individuals by Either Nigetella Salivata or Metformin
Investigating the impact of p53 and SIRT1 in the development of type 2 DM
Read the detailed description
Investigating the impact of p53 and SIRT1 in the development of type 2 DM through the treatment of prediabetic individuals by either nigetella salivata or Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life styleOther
Also called life style management
life sryle control only
MetforminDrug
Also called cidophage
metformin twice daily
Nigetella salivataDrug
Also called NS
NS twice daily
| Study group | Role | What they receive |
|---|---|---|
| life style | Other | life style control only Receives: Other: life style |
| Metformin | Active comparator | Metformin 500 mg twice daily Receives: Drug: Metformin |
| Nigetella salivata | Experimental | NS 450 mg twice daily Receives: Drug: Nigetella salivata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved insulin resistance
Number of patients showing improved insulin resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Apr 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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 DMStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Eman SA Sawan, Msc, Principal investigator, Tanta University - Faculty of PharmacySahar Hegazy, Prof, Principal investigator, Tanta University - Faculty of PharmacyTarek Mostafa, ass. Prof., Study director, Tanta University - Faculty of PharmacySherin El-Nidany, MD, Study chair, Tanta University-Faculty of pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925714
- Sponsor's protocol ID
- dm 2
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa TM, Hegazy SK, Elnaidany SS, Shehabeldin WA, Sawan ES. Nigella sativa as a promising intervention for metabolic and inflammatory disorders in obese prediabetic subjects: A comparative study of Nigella sativa versus both lifestyle modification and metformin. J Diabetes Complications. 2021 Jul;35(7):107947. doi: 10.1016/j.jdiacomp.2021.107947. Epub 2021 May 8.
PubMed 34006388
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of p53 and SIRT1 in the Development of Type 2 DM Through the Treatment of Prediabetic Individuals by Either Nigetella Salivata or Metformin
- ClinicalTrials.gov ID
- NCT03925714
- Acronym / sponsor ID
- dm 2
- Conditions
- DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Apr 2019 (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.
Investigating the impact of p53 and SIRT1 in the development of type 2 DM
Detailed description
Investigating the impact of p53 and SIRT1 in the development of type 2 DM through the treatment of prediabetic individuals by either nigetella salivata or Metformin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| life style | Other | Other: life stylelife style control only |
| Metformin | Active comparator | Drug: MetforminMetformin 500 mg twice daily |
| Nigetella salivata | Experimental | Drug: Nigetella salivataNS 450 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prediabetic subjects.
Key exclusion criteria (2 listed)
- Confirmed diabetes.
- Hepatic or renal impairment.
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 |
|---|---|---|
| life styleAlso: life style managementlife sryle control only | Other | life style |
| MetforminAlso: cidophagemetformin twice daily | Drug | Metformin |
| Nigetella salivataAlso: NSNS twice daily | Drug | Nigetella salivata |
Primary outcome
Number of patients with improved insulin resistance
Time frame: 6 months
Number of patients showing improved insulin resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 34006388Mostafa TM, Hegazy SK, Elnaidany SS, Shehabeldin WA, Sawan ES. Nigella sativa as a promising intervention for metabolic and inflammatory disorders in obese prediabetic subjects: A comparative study of Nigella sativa versus both lifestyle modification and metformin. J Diabetes Complications. 2021 Jul;35(7):107947. doi: 10.1016/j.jdiacomp.2021.107947. Epub 2021 May 8.
- Individual participant dataSharing planned: No
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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.
Eman SA Sawan, Msc principal investigator
Tanta University - Faculty of Pharmacy
Sahar Hegazy, Prof principal investigator
Tanta University - Faculty of Pharmacy
Tarek Mostafa, ass. Prof. study director
Tanta University - Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing life style, Metformin and Nigetella salivata in people with DM, run by Sherief Abd-Elsalam 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 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved insulin resistance (time frame: 6 months). 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 NCT03925714, 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 24 Apr 2019.