Type-2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Participants will be matched by BMI, age, sex and duration of diabetes, then, allocated into one of the two experimental groups using a double-blind randomized approach. All patients will undergo rout
Sponsors
University of Chile, Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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/dL
Exclusion criteria
Exclusion criteria: 1. Insulin therapy. 2. History of ketoacidosis or hyperosmolar hyperglycemic nonketotic syndrome in the previous 6 months. 3. Estimated glomerular filtration rate 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Insulin secretion assessed by a modified frequently sampled intravenous glucose tolerance test (FSIVGTT) 2. Insulin sensitivity assessed by a modified frequently sampled intravenous glucose tolerance test (FSIVGTT) 3. Fasting glycated haemoglobin by HPLC 4. Plasma glucose, 5. Urinary glucose, and 6. Microalbumin determined by an automated dry-chemistry method Determinations will be carried out before and one and two years after supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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") 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 3. Gene expression of selected zinc transporters in peripheral blood mononuclear cells (PBMNC) qPCR using SYBR Green 4. Zn status parameters (plasma and hair zinc) and size of the rapidly exchageable zinc pool (EZP) using Zn stable isotope methodology Determinations will be carried out before and one and two years after supplementation. | — |
Countries
Chile
Contacts
Public ContactJuana Codoceo
Outcome results
None listed