Impact of P53 and SIRT1 in Type 2 Diabetes

April 22, 2019 updated by: Sherief Abd-Elsalam

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prediabetic subjects.

Exclusion Criteria:

  • Confirmed diabetes.
  • Hepatic or renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: life style
life style control only
Other: life style
life sryle control only
Other Names:
  • life style management
Active Comparator: Metformin
Metformin 500 mg twice daily
Drug: Metformin
metformin twice daily
Other Names:
  • cidophage
Experimental: Nigetella salivata
NS 450 mg twice daily
Drug: Nigetella salivata
NS twice daily
Other Names:
  • NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with improved insulin resistance
Time Frame: 6 months
Number of patients showing improved insulin resistance
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Sahar Hegazy, Prof, Tanta University - Faculty of Pharmacy
  • Principal Investigator: Eman SA Sawan, Msc, Tanta University - Faculty of Pharmacy
  • Study Director: Tarek Mostafa, ass. Prof., Tanta University - Faculty of Pharmacy
  • Study Chair: Sherin El-Nidany, MD, Tanta University-Faculty of pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

December 1, 2028

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dm 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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