Zinc as potential co-adjuvant in type-2 diabetes therapy

Completed

Conditions: Type-2 diabetes
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Registration Number: ISRCTN95262434

Lead Sponsor: niversity of Chile, Faculty of Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Men and women with type-2 diabetes (<10 years since diagnosis)
2. Thirty to 65 years old
3. BMI 20-40 kg/m2
4. Stable body weight (weight variation <5%) for at least 3 months prior to screening
5. Glycated hemoglobin (HbA1c) <9 % and/or fasting glycemia <180 mg/d

Exclusion Criteria

1. Insulin therapy.
2. History of ketoacidosis or hyperosmolar hyperglycemic nonketotic syndrome in the previous 6 months.
3. Estimated glomerular filtration rate <60 mL/min.
4. Alanine aminotransferase or aspartate aminotransferase >2.5 times the upper normal limit.
5. Congestive heart failure (grade III-IV according to the New York Heart Association criteria, 1994)
6. Uncontrolled hypertension
7. History of stroke, transient ischemic attack or acute myocardial infarction (previous 5 years). Recent surgery or acute infection (previous 3 months)
8. Major psychiatric disorder affecting compliance
9.. Use of antipsychotic medications
10. Systemic use of glucocorticoid steroids within previous 6 weeks
11. Alcohol intake =2 drinks/day
12. Cancer diagnosis or treatment in the past 5 years, with the exception of cancers that have been cured, and carry a good prognosis
13. HIV positivity
14. Pregnant or lactating women
15. Having taken vitamins mineral supplements in the previous 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Insulin secretion assessed by a modified frequently sampled intravenous glucose tolerance test (FSIVGTT)<br>2. Insulin sensitivity assessed by a modified frequently sampled intravenous glucose tolerance test (FSIVGTT)<br>3. Fasting glycated haemoglobin by HPLC<br>4. Plasma glucose, 5. Urinary glucose, and 6. Microalbumin determined by an automated dry-chemistry method <br><br>Determinations will be carried out before and one and two years after supplementation.<br>

Secondary Outcome Measures

Name	Time	Method
1. Oxidative stress (plasma isoprostane using the Cayman´s 8-Isoprostane ELISA kit, TBARS by the OxiSelect TBARS Assay kit; red blood cell glutathione by an enzymatic method; glutathione peroxidase activity by means of the Biovision glutathione peroxidase activity colorimetric assay kit) <br>2. Inflammation markers (plasma ultra sensitive reactive-C protein by an immunoturbidimetric assay;, Adiponectin, IL-6, and IL-1ß by means of a microsphere Luminex fluorescent technique <br>3. Gene expression of selected zinc transporters in peripheral blood mononuclear cells (PBMNC) qPCR using SYBR Green<br>4. Zn status parameters (plasma and hair zinc) and size of the rapidly exchageable zinc pool (EZP) using Zn stable isotope methodology<br><br>Determinations will be carried out before and one and two years after supplementation.<br>