Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Participants will be randomly allocated to one of four groups:
1. Control group (C): placebo and no muscle strength training
2. Zinc (Zn): 40 mg per day of zinc and no
Sponsors
University of Chile, Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 35-69 years 2. Type 2 diabetes 3. Diagnosed with type 2 diabetes for less than 15 years 4. Sedentary, defined as less than 3 sessions per week of 30 minutes of physical activity and/or sport 5. BMI 20-40 kg/m² for at least 3 months prior to screening 6. Stable body weight (variation <5%) for at least 3 months prior to screening 7. Glycated haemoglobin (HbA1c) 6.5-9.0% and/or fasting glycemia <180 mg/dL
Exclusion criteria
Exclusion criteria: 1. Insulin therapy 2. History of ketoacidosis or hyperosmolar hyperglycemic non-ketotic syndrome in the previous 6 months 3. Estimated glomerular filtration rate (eGFR) 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. Diabetic polyneuropathy, peripheral macrovascular pathology or diabetic foot 8. Proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy 9. History of stroke, transient ischemic attack or acute myocardial infarction in the previous 5 years 10. Recent surgery or acute infection in the previous 3 months 11. Major psychiatric disorder affecting compliance 12. Use of antipsychotic medications 13. Use of anticoagulant medications 14. Uncontrolled thyroid disorders 15. Systemic use of glucocorticoid steroids within previous 6 weeks 16. Osteoarticular or neurologic conditions able to limit physical activity 17. Cancer diagnosis or treatment in the past 5 years, with the exception of cancers that have been cured, and carry a good prognosis 18. Regular alcohol intake >2 portions per day 19. HIV positive 20. Pregnant or lactating women 21. Taken vitamin-mineral supplements during the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An intravenous glucose tolerance test after an overnight fast will be complete, with blood samples drawn 15 and 5 minutes before a glucose bolus (0.3 g/kg body weight as 50% glucose in saline solution) administered over 2 minutes. Samples will then be drawn at 2, 3, 4, 5, 6, 8, 10, 12, 14, 19, 22, 24, 27, 30, 40, 50, 70, 90, 120, 150, and 180 min after the bolus. Insulin (0.05 U/kg body weight) will be infused over 5 minutes, beginning 20 minutes after the glucose bolus. The data will be analysed using the MINMOD program for the following insulin sensitivity indices: 1. Insulin sensitivity (Si) 2. Acute insulin response to glucose (AINg) 3. Glucose effectiveness (Sg) 4. Fractional metabolic clearance rate of insulin (kI) 5. Disposition index (DI) This procedure will be carried out at the baseline and after 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical control of diabetes, assessed using a blood pressure, skin and comprehensive foot examination carried out by a Diabetes Nutrition specialist physician at the baseline and after 12 and 24 weeks 2. Anthropometric parameters, assessed using standardised methods at the baseline and after 24 weeks: 2.1. Weight, assessed using a measuring scale 2.2. Height, assessed using a stadiometer 2.3. Waist circumference, assessed using a measuring tape 3. Food and nutrient intake, assessed using food history and three-day record questionnaires at the baseline and after 24 weeks 4. Body composition, assessed using dual X-ray absorptometry (DXA) at the baseline and after 24 weeks 5. Zinc status parameters: 5.1. Plasma zinc, assessed using atomic absorption spectrophotometry of blood samples at the baseline and after 12 and 24 weeks 5.2. Size of the rapidly exchangeable zinc pool, assessed using stape isotope methodology from spot urine samples taken from days 3-8 after infusion 6. Metabolic status under overnight fasting conditions, assessed using clinical laboratory routine procedures of blood samples at the baseline and after 12 and 24 weeks: 6.1. Plasma HbA1c levels, assessed using high-performance liquid chromatography 6.2. Glucose levels, assessed using an endpoint colorimetric assay 6.3. Haemoglobin levels, assessed using a Coulter counter 6.4. Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides), assessed using an endpoint colorimetric assay 7. Plasma inflammation markers, assessed from blood samples at the baseline and after 12 and 24 weeks: 7.1. Plasma high-sensitive C-reactive protein (CRP), assessed using immunoturbidimetry 7.2. Adiponectin, assessed using ELISA | — |
Countries
Chile
Contacts
Public ContactJuana Codoceo
Outcome results
None listed