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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type II
• Intervention / Treatment: Drug: zinc supplement plus vitamin A and E; Drug: vitamin A and E

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 6, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Antioxidants; Anticarcinogenic Agents; Vitamins; Vitamin A; Retinol palmitate
• Other Study ID Numbers: CL (1461)