Impact of P53 and SIRT1 in Type 2 Diabetes

NCT ID: NCT03925714

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2028-12-31

Brief Summary

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Investigating the impact of p53 and SIRT1 in the development of type 2 DM

Detailed Description

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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

Conditions

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DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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life style

life style control only

Group Type OTHER

life style

Intervention Type OTHER

life sryle control only

Metformin

Metformin 500 mg twice daily

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

metformin twice daily

Nigetella salivata

NS 450 mg twice daily

Group Type EXPERIMENTAL

Nigetella salivata

Intervention Type DRUG

NS twice daily

Interventions

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life style

life sryle control only

Intervention Type OTHER

Metformin

metformin twice daily

Intervention Type DRUG

Nigetella salivata

NS twice daily

Intervention Type DRUG

Other Intervention Names

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life style management cidophage NS

Eligibility Criteria

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Inclusion Criteria

* Prediabetic subjects.

Exclusion Criteria

* Confirmed diabetes.
* Hepatic or renal impairment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eman SA Sawan, Msc

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Pharmacy

Sahar Hegazy, Prof

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Pharmacy

Tarek Mostafa, ass. Prof.

Role: STUDY_DIRECTOR

Tanta University - Faculty of Pharmacy

Sherin El-Nidany, MD

Role: STUDY_CHAIR

Tanta University-Faculty of pharmacy

Locations

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Sherief Abd-Elsalam

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

00201000040794

References

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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.

Reference Type DERIVED
PMID: 34006388 (View on PubMed)

Other Identifiers

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dm 2

Identifier Type: -

Identifier Source: org_study_id

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