NCT06751823

Brief Summary

investigation of the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 17, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

type 2 DM,zinc

Outcome Measures

Primary Outcomes (4)

  • zinc serum level in the participnats

    investigate the impact of zinc serum level on the development of DM

    "through study completion, an average of 1 year"

  • Dietary micronutrient assessment using food questionnaire

    Dietary micronutrient assessment using food questionnaire adopted from a questionnaire for screening the micronutrient intake of economically active South African adults

    "through study completion, an average of 1 year"

  • Trace elements daily intake calculation

    It will be calculated by multiplying the element contents measured in food (μg/kg) with the intake as estimated by the food micronutrient questionnaire (g/day).

    "through study completion, an average of 1 year"

  • the dietary intake by kilogram (kg) of body weight (bw)

    the dietary intake by kilograms (kg) of body weight (bw) by dividing by the weight of participants.

    "through study completion, an average of 1 year"

Secondary Outcomes (1)

  • HbA1C mesurements

    "through study completion, an average of 1 year"

Study Arms (2)

control

haelthy volunteers

Type 2 DM patients

patients of Type 2 DM with no known complications

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

type 2 DM patients with no complication in comparison with health volunteers

You may qualify if:

  • confirmed Type 2 DM with no known complication
  • more than or equal 40 years old

You may not qualify if:

  • pregnancy and lactation type 1DM known DM complication other endocrinological disorders malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitsl

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • sara eladwy, lecturer

    Helioplis university

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 30, 2024

Study Start

January 1, 2024

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

December 30, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

data will be assigned codes with no needs to share IPD

Locations