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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type II
• Interventions: Drug: zinc supplement plus vitamin A and E; Drug: vitamin A and E

• Registration Number: NCT03112382
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-08
• Study First Posted: 2017-04-13
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-06
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zinc supplement plus vitamin A and E	zinc supplement plus vitamin A and E	patients will be receiving zinc supplement plus vitamin A and E for 3 months.
vitamin A and E	vitamin A and E	patients will be receiving equivalent dose of vitamin A and E only for 3 months

Primary Outcome Measures

Name	Time	Method
SLC30A8 rs13266634 polymorphism	one year	genetic screening of SLC30A8 : solute carrier family 30 member 8
serum zinc	at base line

Secondary Outcome Measures

Name	Time	Method
creatinine level	baseline
change from baseline in HbA1c at three months	base line and three months
serum Mg	baseline
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 fasting serum insulin at three months	baseline and three months
serum Iron	baseline
change from baseline in total serum Calcium at three months	baseline and three months
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 ALT level at three months	baseline and three months

Trial Locations

Locations (1)

theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,; 🇪🇬 Cairo, Egypt