Type 2 DiabetesNCT06751823
Evaluation of Zinc in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Heliopolis University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 195 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 17 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: type 2 DM patients with no complication in comparison with health volunteers
Who may be able to join
- confirmed Type 2 DM with no known complication
- more than or equal 40 years old
Who cannot join
- pregnancy and lactation type 1DM known DM complication other endocrinological disorders malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Serum Zinc Levels and Intake in Type 2 Diabetes: Impact on Pathogenesis and Glycemic Control"
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.
Read the detailed description
The relationship between the pathophysiology of diabetes mellitus and trace element dysregulation emphasizes how crucial it is to maintain appropriate micronutrient status in order to manage this chronic metabolic disease. One promising strategy for enhancing glycemic control and lowering the risk of diabetic complications may be to address these underlying dietary imbalances.
Accordingly, the aim is to investigate the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 DM,, zinc
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | haelthy volunteers | |
| Type 2 DM patients | patients of Type 2 DM with no known complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
zinc serum level in the participnats
investigate the impact of zinc serum level on the development of DM
Measured: "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
Measured: "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).
Measured: "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.
Measured: "through study completion, an average of 1 year"
Secondary outcomes (1)
HbA1C mesurements
investigate the impact of serum zinc level on the glycemic control
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heliopolis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara mostafa ElAdawy, Heliopolis University
- Investigators
- sara eladwy, lecturer, Principal investigator, Helioplis university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751823
- Sponsor's protocol ID
- MD-81-2024
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be assigned codes with no needs to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Serum Zinc Levels and Intake in Type 2 Diabetes: Impact on Pathogenesis and Glycemic Control"
- ClinicalTrials.gov ID
- NCT06751823
- Acronym / sponsor ID
- MD-81-2024
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 DM,, zinc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Heliopolis UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The relationship between the pathophysiology of diabetes mellitus and trace element dysregulation emphasizes how crucial it is to maintain appropriate micronutrient status in order to manage this chronic metabolic disease. One promising strategy for enhancing glycemic control and lowering the risk of diabetic complications may be to address these underlying dietary imbalances.
Accordingly, the aim is to investigate the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –haelthy volunteers |
| Type 2 DM patients | – | –patients of Type 2 DM with no known complications |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 DM patients with no complication in comparison with health volunteers
Key inclusion criteria (2 listed)
- confirmed Type 2 DM with no known complication
- more than or equal 40 years old
Key exclusion criteria (1 listed)
- pregnancy and lactation type 1DM known DM complication other endocrinological disorders malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
zinc serum level in the participnats
Time frame: "through study completion, an average of 1 year"
investigate the impact of zinc serum level on the development of DM
Dietary micronutrient assessment using food questionnaire
Time frame: "through study completion, an average of 1 year"
Dietary micronutrient assessment using food questionnaire adopted from a questionnaire for screening the micronutrient intake of economically active South African adults
Trace elements daily intake calculation
Time frame: "through study completion, an average of 1 year"
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).
the dietary intake by kilogram (kg) of body weight (bw)
Time frame: "through study completion, an average of 1 year"
the dietary intake by kilograms (kg) of body weight (bw) by dividing by the weight of participants.
1 secondary outcome
HbA1C mesurements
Time frame: "through study completion, an average of 1 year"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No. data will be assigned codes with no needs to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sara eladwy, lecturer principal investigator
Helioplis university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Heliopolis University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zinc serum level in the participnats (time frame: "through study completion, an average of 1 year"). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.