Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID03925714

Investigating the Impact of p53 and SIRT1 in the Development of Type 2 DM Through Treatment of Prediabetic Individuals by Nigetella Salivata or Metformin

Led by Sherief Abd-Elsalam · Updated on 2019-04-24

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how two proteins, p53 and SIRT1, may affect the development of type 2 diabetes. The study focuses on people who have prediabetes and aims to understand the impact of treatments with either Nigetella salivata, a natural substance, or the medication Metformin. This is a Phase 3 clinical trial exploring these options to see their effects on insulin resistance. Participants will be randomly assigned to one of three groups: lifestyle control only, Metformin taken 500 mg twice daily, or Nigetella salivata taken 450 mg twice daily. The treatments will be given over a period of time to compare how each affects insulin resistance in people with prediabetes. No blinding is involved, meaning both researchers and participants know which treatment is given. During the study, participants will be monitored to measure changes in insulin resistance over six months. Researchers will assess who shows improvement in insulin resistance, which is a key factor in diabetes development. Participants will follow their assigned treatments and lifestyle guidance while being regularly evaluated to track progress and study outcomes.

CONDITIONS

Brief Title

Impact of P53 and SIRT1 in Type 2 Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Prediabetic subjects.
Not Eligible

You will not qualify if you...

  • Confirmed diabetes.
  • Hepatic or renal impairment.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive either lifestyle control, Metformin twice daily, or Nigetella salivata twice daily to manage prediabetes.

Monthly visits for 6 months

Trial Site Locations

Total: 1 location

1

Sherief Abd-Elsalam

Cairo, Egypt

Actively Recruiting

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Research Team

S

Sherief Abd-Elsalam, ass. prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial

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.

Tarek M Mostafa, Sahar K Hegazy, Sherin S Elnaidany...

https://pubmed.ncbi.nlm.nih.gov/34006388