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

Primary Purpose

Diabetes Mellitus, Type II

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

zinc supplement plus vitamin A and E

vitamin A and E

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type II

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

zinc supplement plus vitamin A and E

vitamin A and E

no vitamins

Arm Description

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

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

patients will be observed for 3 months

Outcomes

Primary Outcome Measures

SLC30A8 rs13266634 polymorphism

genetic screening of SLC30A8 : solute carrier family 30 member 8

serum zinc

Secondary Outcome Measures

change from baseline in fasting and 2hr post prandial blood glucose at three months

change from baseline in HbA1c at three months

change from baseline in lipid profile at three months

lipid profile: total cholesterol, triglyceride, HDL, LDL.

change from baseline in fasting serum insulin at three months

change from baseline in ALT level at three months

serum Mg

creatinine level

serum Iron

change from baseline in total serum Calcium at three months

Full Information

NCT ID

NCT03112382

First Posted

April 4, 2017

Last Updated

August 6, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03112382

Brief Title

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

Acronym

SLC30A8

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type II

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

zinc supplement plus vitamin A and E

Arm Type

Active Comparator

Arm Description

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

Arm Title

vitamin A and E

Arm Type

Active Comparator

Arm Description

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

Arm Title

no vitamins

Arm Type

No Intervention

Arm Description

patients will be observed for 3 months

Intervention Type

Drug

Intervention Name(s)

zinc supplement plus vitamin A and E

Intervention Type

Drug

Intervention Name(s)

vitamin A and E

Primary Outcome Measure Information:

Title

SLC30A8 rs13266634 polymorphism

Description

genetic screening of SLC30A8 : solute carrier family 30 member 8

Time Frame

one year

Title

serum zinc

Time Frame

at base line

Secondary Outcome Measure Information:

Title

change from baseline in fasting and 2hr post prandial blood glucose at three months

Time Frame

at base line and after three months

Title

change from baseline in HbA1c at three months

Time Frame

base line and three months

Title

change from baseline in lipid profile at three months

Description

lipid profile: total cholesterol, triglyceride, HDL, LDL.

Time Frame

base line and three months

Title

change from baseline in fasting serum insulin at three months

Time Frame

baseline and three months

Title

change from baseline in ALT level at three months

Time Frame

baseline and three months

Title

serum Mg

Time Frame

baseline

Title

creatinine level

Time Frame

baseline

Title

serum Iron

Time Frame

baseline

Title

change from baseline in total serum Calcium at three months

Time Frame

baseline and three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

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

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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