Diabetes Mellitus, Type IIPhase 4SLC30A8NCT03112382
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing zinc supplement plus vitamin A and E and vitamin A and E in people with Diabetes Mellitus, Type II, run by Cairo University at 1 site in Egypt.
Trial summary
Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- zinc supplement plus vitamin A and E and vitamin A and E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 4
- 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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Established diagnosis of type 2 diabetes mellitus.
- Age between 20 and 64 years.
- BMI < 40 kg/m2.
- On fixed oral hypoglycemic dosage for at least 3 months.
- Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
- Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).
Who cannot join
- Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
- Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
- Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
- Pregnant or intend to be pregnant for t least 3 months or lactating women.
- Those who were receiving insulin preparations as a part of diabetes management.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,
Cairo
About this study
Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- zinc supplement plus vitamin A and E, vitamin A and E
- 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.
zinc supplement plus vitamin A and EDrug
vitamin A and EDrug
| Study group | Role | What they receive |
|---|---|---|
| zinc supplement plus vitamin A and E | Active comparator | patients will be receiving zinc supplement plus vitamin A and E for 3 months. Receives: Drug: zinc supplement plus vitamin A and E |
| vitamin A and E | Active comparator | patients will be receiving equivalent dose of vitamin A and E only for 3 months Receives: Drug: vitamin A and E |
| no vitamins | No intervention | patients will be observed for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLC30A8 rs13266634 polymorphism
genetic screening of SLC30A8 : solute carrier family 30 member 8
Measured: one year
serum zinc
Measured: at base line
Secondary outcomes (9)
change from baseline in fasting and 2hr post prandial blood glucose at three months
Measured: at base line and after three months
change from baseline in HbA1c at three months
Measured: base line and three months
change from baseline in lipid profile at three months
lipid profile: total cholesterol, triglyceride, HDL, LDL.
Measured: base line and three months
change from baseline in fasting serum insulin at three months
Measured: baseline and three months
change from baseline in ALT level at three months
Measured: baseline and three months
serum Mg
Measured: baseline
creatinine level
Measured: baseline
serum Iron
Measured: baseline
change from baseline in total serum Calcium at three months
Measured: baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112382
- Sponsor's protocol ID
- CL (1461)
- Acronym
- SLC30A8
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03112382
- Acronym / sponsor ID
- SLC30A8 / CL (1461)
- Conditions
- Diabetes Mellitus, Type II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Apr 2017 (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.
Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zinc supplement plus vitamin A and E | Active comparator | Drug: zinc supplement plus vitamin A and Epatients will be receiving zinc supplement plus vitamin A and E for 3 months. |
| vitamin A and E | Active comparator | Drug: vitamin A and Epatients will be receiving equivalent dose of vitamin A and E only for 3 months |
| no vitamins | No intervention | –patients will be observed for 3 months |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Established diagnosis of type 2 diabetes mellitus.
- Age between 20 and 64 years.
- BMI < 40 kg/m2.
- On fixed oral hypoglycemic dosage for at least 3 months.
- Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
Key exclusion criteria (5 listed)
- Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
- Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
- Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
- Pregnant or intend to be pregnant for t least 3 months or lactating women.
- Those who were receiving insulin preparations as a part of diabetes management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc supplement plus vitamin A and E | Drug | zinc supplement plus vitamin A and E |
| vitamin A and E | Drug | vitamin A and E |
Primary outcome
SLC30A8 rs13266634 polymorphism
Time frame: one year
genetic screening of SLC30A8 : solute carrier family 30 member 8
serum zinc
Time frame: at base line
9 secondary outcomes
change from baseline in fasting and 2hr post prandial blood glucose at three months
Time frame: at base line and after three months
change from baseline in HbA1c at three months
Time frame: base line and three months
change from baseline in lipid profile at three months
Time frame: base line and three months
change from baseline in fasting serum insulin at three months
Time frame: baseline and three months
change from baseline in ALT level at three months
Time frame: baseline and three months
serum Mg
Time frame: baseline
creatinine level
Time frame: baseline
serum Iron
Time frame: baseline
change from baseline in total serum Calcium at three months
Time frame: baseline and three months
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 8 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zinc supplement plus vitamin A and E and vitamin A and E in people with Diabetes Mellitus, Type II, run by Cairo 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 6 inclusion and 5 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 8 Aug 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SLC30A8 rs13266634 polymorphism (time frame: one year). The study lists 2 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 8 Aug 2017.