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
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
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
You may qualify if you...
Prediabetic subjects.
You will not qualify if you...
Confirmed diabetes.
Hepatic or renal impairment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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.
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...