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

NCT ID: NCT03112382

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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zinc supplement plus vitamin A and E

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

Group Type ACTIVE_COMPARATOR

zinc supplement plus vitamin A and E

Intervention Type DRUG

vitamin A and E

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

Group Type ACTIVE_COMPARATOR

vitamin A and E

Intervention Type DRUG

no vitamins

patients will be observed for 3 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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zinc supplement plus vitamin A and E

Intervention Type DRUG

vitamin A and E

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Said

Assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CL (1461)

Identifier Type: -

Identifier Source: org_study_id

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