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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03112382

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type II	Drug: zinc supplement plus vitamin A and E Drug: vitamin A and E	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 [base line and three months]
lipid profile: total cholesterol, triglyceride, HDL, LDL.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Said, Assisstant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03112382

Other Study ID Numbers:

CL (1461)

First Posted:

Apr 13, 2017

Last Update Posted:

Aug 8, 2017

Last Verified:

Aug 1, 2017

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Vitamins

Vitamin A

Retinol palmitate

Study Results

No Results Posted as of Aug 8, 2017