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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: vitamin A and E; Drug: zinc supplement plus vitamin A and E

Study type: Interventional

Funder types: Other

Identifiers

NCT03112382

CL (1461)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

zinc supplement plus vitamin A and E

Active Comparator group

Description:

patients will be receiving zinc supplement plus vitamin A and E for 3 months.

Treatment:

Drug: zinc supplement plus vitamin A and E

vitamin A and E

Active Comparator group

Description:

patients will be receiving equivalent dose of vitamin A and E only for 3 months

Treatment:

Drug: vitamin A and E

no vitamins

No Intervention group

Description:

patients will be observed for 3 months