Diabetes Mellitus, Type II
Conditions
Brief 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
Interventions
DRUGzinc supplement plus vitamin A and E
DRUGvitamin A and E
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SLC30A8 rs13266634 polymorphism | one year | genetic screening of SLC30A8 : solute carrier family 30 member 8 |
| serum zinc | at base line | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in lipid profile at three months | base line and three months | lipid profile: total cholesterol, triglyceride, HDL, LDL. |
| 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 | — |
| change from baseline in fasting and 2hr post prandial blood glucose at three months | at base line and after three months | — |
| creatinine level | baseline | — |
| serum Iron | baseline | — |
| change from baseline in total serum Calcium at three months | baseline and three months | — |
| serum Mg | baseline | — |
| change from baseline in HbA1c at three months | base line and three months | — |
Countries
Egypt
Outcome results
None listed