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

Diabetes Mellitus, Type II Clinical Trial

— SLC30A8  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112382
• Other study ID #: CL (1461)
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2017
• Last updated: August 6, 2017
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• zinc supplement plus vitamin A and E

• vitamin A and E

Locations

Country	Name	City	State
Egypt	theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SLC30A8 rs13266634 polymorphism	genetic screening of SLC30A8 : solute carrier family 30 member 8	one year
Primary	serum zinc		at base line
Secondary	change from baseline in fasting and 2hr post prandial blood glucose at three months		at base line and after three months
Secondary	change from baseline in HbA1c at three months		base line and three months
Secondary	change from baseline in lipid profile at three months	lipid profile: total cholesterol, triglyceride, HDL, LDL.	base line and three months
Secondary	change from baseline in fasting serum insulin at three months		baseline and three months
Secondary	change from baseline in ALT level at three months		baseline and three months
Secondary	serum Mg		baseline
Secondary	creatinine level		baseline
Secondary	serum Iron		baseline
Secondary	change from baseline in total serum Calcium at three months		baseline and three months