NCT05684406

Brief Summary

Type 2 diabetes mellitus, which is characterised by a combination of insulin resistance and insufficient insulin secretion is a major contributor to the burden of morbidity and mortality worldwide. the mitochondrial genome contains multiple copies per cell. Because of its close proximity with higher levels of reactive oxidative species, mitochondrial DNA is prone to oxidative stress; which may lead to mitochondrial dysfunction, characterized by lowered oxidative capacity and reduction in energy production. Mitochondrial dysfunction is associated with aging process and can affect cellular functions and thereby results in a variety of human diseases such as cancer, neurodegenerative diseases, cardiovascular diseases, diabetes and metabolic syndrome . Telomere length reflects the cumulative damage from those exposure factors and can be used as a potential indicator of biological aging. Shorter telomere length has been linked to the development of a variety of age-related diseases, such as cancer, cardiovascular disease and diabetes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

December 23, 2022

Last Update Submit

January 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluate the potential of peripheral blood mtDNA-CN as biomarker in type 2 diabetic patients

    evaluate the potential of peripheral blood mtDNA-CN as biomarker in type 2 diabeticients pat patients by Real Time PCR

    within 3 days after collection of samples

Secondary Outcomes (1)

  • evaluate the potential of leukocyte telomere length as biomarker in type 2 diabetic patients

    within 3 days after collection of samples

Study Arms (2)

Group I

patients with type 2 diabetes mellitus

Genetic: Genotyping

Group II

apparently healthy controls with no chronic illness of matched age and sex

Genetic: Genotyping

Interventions

GenotypingGENETIC

Genotyping by Real Time PCR

Group IGroup II

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with type 2 diabetes mellitus aged from 15 years and above, in internal medicine department of Sohag University Hospital and healthy controls of matched age and sex

You may qualify if:

  • This study will include patients who have type 2 diabetes mellitus.

You may not qualify if:

  • Patients who have any other chronic illness.
  • Patients who have cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Univversity

Sohag, 82515, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Genotype

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Hend Muhammed Naguib

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hend Muhammed Naguib

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 13, 2023

Study Start

January 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations