Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Drug: zinc supplement plus vitamin A and E
* Drug: vitamin A and E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zinc supplement plus vitamin A and E<br>patients will be receiving zinc supplement plus vitamin A and E for 3 months. | Drug: zinc supplement plus vitamin A and E<br> <br> |
| Active Comparator: vitamin A and E<br>patients will be receiving equivalent dose of vitamin A and E only for 3 months | Drug: vitamin A and E<br> <br> |
| No Intervention: no vitamins<br>patients will be observed for 3 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLC30A8 rs13266634 polymorphism | genetic screening of SLC30A8 : solute carrier family 30 member 8 | one year | 
| serum zinc |  | at base line | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in fasting and 2hr post prandial blood glucose at three months |  | at base line and after three months | 
| change from baseline in HbA1c at three months |  | base line and three months | 
| change from baseline in lipid profile at three months | lipid profile: total cholesterol, triglyceride, HDL, LDL. | base line and three months | 
| change from baseline in fasting serum insulin at three months |  | baseline and three months | 
| change from baseline in ALT level at three months |  | baseline and three months | 
| serum Mg |  | baseline | 
| creatinine level |  | baseline | 
| serum Iron |  | baseline | 
| change from baseline in total serum Calcium at three months |  | baseline and three months |