NCT03925714

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
32mo left

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2019Dec 2028

Study Start

First participant enrolled

April 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

9.7 years

First QC Date

April 22, 2019

Last Update Submit

April 22, 2019

Conditions

DM

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved insulin resistance

    Number of patients showing improved insulin resistance

    6 months

Study Arms (3)

life style

OTHER

life style control only

Other: life style

Metformin

ACTIVE COMPARATOR

Metformin 500 mg twice daily

Drug: Metformin

Nigetella salivata

EXPERIMENTAL

NS 450 mg twice daily

Drug: Nigetella salivata

Interventions

life styleOTHER

life sryle control only

Also known as: life style management
life style
MetforminDRUG

metformin twice daily

Also known as: cidophage
Metformin
Nigetella salivataDRUG

NS twice daily

Also known as: NS
Nigetella salivata

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prediabetic subjects.

You may not qualify if:

  • Confirmed diabetes.
  • Hepatic or renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34006388DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Eman SA Sawan, Msc

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Sahar Hegazy, Prof

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Tarek Mostafa, ass. Prof.

    Tanta University - Faculty of Pharmacy

    STUDY DIRECTOR

  • Sherin El-Nidany, MD

    Tanta University-Faculty of pharmacy

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

April 1, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)