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OpenTrials
Completed

NCT Number: NCT03112382

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

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

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Key information

Conditions

Diabetes Mellitus, Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zinc supplement plus vitamin A and E

Drug

vitamin A and E

Drug

Primary outcomes

  1. SLC30A8 rs13266634 polymorphism

    Time frame: one year

    genetic screening of SLC30A8 : solute carrier family 30 member 8

  2. serum zinc

    Time frame: at base line

Secondary outcomes

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

    Time frame: at base line and after three months

  2. change from baseline in HbA1c at three months

    Time frame: base line and three months

  3. change from baseline in lipid profile at three months

    Time frame: base line and three months

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

  4. change from baseline in fasting serum insulin at three months

    Time frame: baseline and three months

  5. change from baseline in ALT level at three months

    Time frame: baseline and three months

  6. serum Mg

    Time frame: baseline

  7. creatinine level

    Time frame: baseline

  8. serum Iron

    Time frame: baseline

  9. change from baseline in total serum Calcium at three months

    Time frame: baseline and three months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: SLC30A8

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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